| PMA Number | Suppl. Type | Device Name | Applicant | Decision Date |
|---|---|---|---|---|
|
P010014
S114 |
30-Day Notice | Oxford Cementless Partial Knee System |
Biomet Manufacturing Corp |
03/06/2026 |
|
P010015
S582 |
30-Day Notice | Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P |
Medtronic, Inc. | 03/06/2026 |
|
P010031
S920 |
30-Day Notice | Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt |
Medtronic Cardiac Rhythm Disease Management |
03/06/2026 |
|
P030036
S157 |
30-Day Notice | SelectSecure Lead | Medtronic Cardiac Rhythm Disease Management |
03/06/2026 |
|
P040029
S021 |
Normal 180 Day Track | Euclid Orthokeratology (oprifocon A) Contact Lenses For Overnight Wear, Euclid Orthokeratology (tisilfocon A) Contact Le |
Euclid Vision Corporation |
03/06/2026 |
|
P100009
S083 |
30-Day Notice | MitraClip NTR/XTR Clip Delivery System; MitraClip G4 System |
Abbott Medical | 03/06/2026 |
|
P140010
S098 |
Normal 180 Day Track | IN.PACT™ 018 Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter |
Medtronic, Inc. | 03/06/2026 |
|
P200037
S018 |
Normal 180 Day Track | ASSURE Wearable Cardioverter Defibrillator (WCD) System |
Kestra Medical Technologies, Inc. |
03/06/2026 |
|
P200046
S048 |
Normal 180 Day Track No User Fee |
Harmony™ TPV System | Medtronic, Inc. | 03/06/2026 |
|
P220012
S068 |
30-Day Notice | Aurora EV ICD; Epsila EV Extravascular Lead |
Medtronic, Inc. | 03/06/2026 |
|
P230007
S020 |
30-Day Notice | TriClip G4 System | Abbott Medical | 03/06/2026 |
|
P240013
S020 |
30-Day Notice | Sphere-9 Catheter (AFR-00001) | Medtronic, Inc. | 03/06/2026 |
|
P250017
S002 |
30-Day Notice | GORE® VIABAHN® FORTEGRA Venous Stent |
W.L. Gore & Associates, Inc. |
03/06/2026 |
|
P900009
S050 |
30-Day Notice | SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A |
Bioventus, LLC | 03/06/2026 |
|
P910073
S187 |
Normal 180 Day Track No User Fee |
ENDOTAK RELIANCE™ / RELIANCE 4-FRONT™ Pace/sense Defibrillation Leads |
Boston Scientific | 03/06/2026 |
|
P920015
S304 |
30-Day Notice | HV Splitter/ Adaptor Kit | Medtronic, Inc. | 03/06/2026 |
|
P980016
S953 |
30-Day Notice | Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR I CD; Ev |
Medtronic Cardiac Rhythm Disease Management |
03/06/2026 |
|
P980052
S017 |
135 Review Track For 30-Day Notice |
TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis |
TMJ Concepts | 03/06/2026 |
|
P050023
S208 |
30-Day Notice | Acticor 7 VR-T (429526); Rivacor 7 VR-T (429536); Rivacor 5 VR-T (429565); Rivacor 3 VR-T (429574); Acticor 7 VR-T DX (4 |
Biotronik, Inc. | 03/05/2026 |
|
P070008
S176 |
30-Day Notice | Edora 8 HF-T QP (407137); Edora 8 HF-T (407138); Evity 8 HF-T QP (407139); Evity 8 HF-T (407140); Enitra 8 HF-T QP (4071 |
Biotronik, Inc. | 03/05/2026 |
|
P150038
S042 |
Real-Time Process | Exablate Model 4000 Type 1.0 And 1.1 (“Exablate Neuro”; “Exablate Prime”) |
Insightec | 03/05/2026 |
|
P160026
S066 |
30-Day Notice | LIFEPAK 35 Monitor/defibrillator | Physio-Control, Inc. | 03/05/2026 |
|
P200039
S020 |
30-Day Notice | Shockwave™ Lntravascular Lithotripsy (IVL) System With Shockwave C2 Aero Coronary IVL Catheter |
Shockwave Medical, Inc. | 03/05/2026 |
|
P900056
S223 |
30-Day Notice | ROTAPRO™ Rotational Atherectomy System |
Boston Scientific Corp | 03/05/2026 |
|
P920048
S028 |
30-Day Notice | Rapid Ffn For The TLiIQ System | Hologic, Inc. | 03/05/2026 |
|
P920048
S029 |
30-Day Notice | Rapid Ffn For The TLiIQ System | Hologic, Inc. | 03/05/2026 |
|
P950037
S286 |
30-Day Notice | Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En |
Biotronik, Inc. | 03/05/2026 |
|
P980023
S144 |
30-Day Notice | Acticor Sky VR-T (481989); Rivacor Sky VR-T (481984); Rivacor Rise VR-T (482020); Rivacor Aura VR-T (482015); Acticor Sk |
Biotronik, Inc. | 03/05/2026 |
|
P010031
S919 |
30-Day Notice | Cobalt MRI CRT-D (DTPB2Dl, DTPB2D4, DTPB2Ql, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2Dl, DTPA2D4, DTPA2Ql, DTPA2QQ); Crome M |
Medtronic Cardiac Rhythm Disease Management |
03/04/2026 |
|
P030016
S051 |
135 Review Track For 30-Day Notice |
The EVO/EVO+ Visian Implantable Collamer Lens (ICL) |
STAAR Surgical Company | 03/04/2026 |
|
P080011
S197 |
30-Day Notice | Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses For Extended Wear |
CooperVision, Inc. | 03/04/2026 |
|
P080011
S198 |
30-Day Notice | Biofinity Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses For Extended Wear |
CooperVision, Inc. | 03/04/2026 |
|
P160045
S052 |
Special (Immediate Track) |
Oncomine™ Dx Target Test | Life Technologies Corporation |
03/04/2026 |
|
P160054
S119 |
30-Day Notice | HeartMate 3™ Left Ventricular Assist System |
Abbott Medical | 03/04/2026 |
|
P160054
S120 |
30-Day Notice | HeartMate 3™ Left Ventricular Assist System |
Abbott Medical | 03/04/2026 |
|
P230022
S003 |
Real-Time Process | Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class |
Element Science, Inc. | 03/04/2026 |
|
P970003
S253 |
30-Day Notice | VNS Therapy® System | LivaNova USA, Inc. | 03/04/2026 |
|
P980016
S952 |
30-Day Notice | Cobalt MRI ICD (DDPB3Dl, DDPB3D4, DVPB3Dl, DVPB3D4); Cobalt XT MRI ICD (DDPA2Dl, DDPA2D4, DVPA2Dl, DVPA2D4); Crome MRI I |
Medtronic Cardiac Rhythm Disease Management |
03/04/2026 |
|
P200036
S010 |
Normal 180 Day Track No User Fee |
Ecoin Peripheral Neurostimulator | Valencia Technologies Corporation |
03/03/2026 |
|
P240013
S019 |
30-Day Notice | HexaGen™ RF Generator | Medtronic, Inc. | 03/03/2026 |
| P250008 | Original | Claire™ OCT System | Perimeter Medical Imaging Ai, Inc. |
03/03/2026 |
|
P990064
S094 |
Normal 180 Day Track | Mosaic Neo Mitral Bioprosthesis | Medtronic, Inc. | 03/03/2026 |
|
P040020
S118 |
30-Day Notice | AcrySof® IQ ReSTOR Posterior Chamber Intraocular Lenses |
Alcon Research, Ltd. | 03/02/2026 |
|
P050007
S048 |
30-Day Notice | StarClose SE™ Vascular Closure System |
Abbott Vascular Devices | 03/02/2026 |
|
P160054
S114 |
Real-Time Process | HeartMate 3™ Left Ventricular Assist System (LVAS) |
Abbott Medical | 03/02/2026 |
|
P190018
S049 |
30-Day Notice | Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) And Clareon® PanOptix Hydrophobic Acrylic IOL |
Alcon Laboratories, LLC | 03/02/2026 |
|
P210007
S011 |
30-Day Notice | Vivistim® System | MicroTransponder, Inc. | 03/02/2026 |
|
P230040
S029 |
30-Day Notice | Cordella Pulmonary Artery Sensor System (CorPASS) |
Endotronix, Inc. | 03/02/2026 |
|
P930014
S162 |
30-Day Notice | AcrySof® Posterior Chamber Intraocular Lens And Delivery Systems |
Alcon Laboratories, Inc. | 03/02/2026 |
|
P960043
S131 |
30-Day Notice | Perclose ProGlide™ Suture-Mediated Closure System; Perclose™ ProStyle™ Suture-Mediated Closure And Repair System |
Abbott Vascular, Inc. | 03/02/2026 |
|
P230020
S007 |
30-Day Notice | Altius® Direct Electrical Nerve Stimulation System |
Neuros Medical, Inc. | 02/28/2026 |
|
P000027
S044 |
30-Day Notice | Elecsys Free PSA Assay | Roche Diagnostics Corp. | 02/27/2026 |
|
P040034
S041 |
Real-Time Process | DuraSeal Dural Sealant System | Integra LifeSciences Corporation |
02/27/2026 |
|
P080013
S030 |
Real-Time Process | DuraSeal Exact Spine Sealant System | Integra LifeSciences Corporation |
02/27/2026 |
|
P080025
S340 |
30-Day Notice | InterStim™ Therapy System, Verify™ Evaluation System |
Medtronic Neuromodulation |
02/27/2026 |
|
P100021
S134 |
30-Day Notice | Endurant™, Endurant™ II/lls Stent Graft System |
Medtronic Vascular | 02/27/2026 |
|
P100040
S074 |
30-Day Notice | Valiant™ Thoracic Stent Graft With The Captivia™ Delivery System |
Medtronic Vascular | 02/27/2026 |
|
P100045
S086 |
Normal 180 Day Track | Next Gen Patient System – CM1200 CardioMEMS HERO Device |
Abbott Medical | 02/27/2026 |
|
P180025
S015 |
30-Day Notice | MANTA™ Vascular Closure Device | Teleflex Medical, LLC | 02/27/2026 |
|
P180046
S105 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
02/27/2026 |
|
P180046
S107 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
02/27/2026 |
|
P190006
S105 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
02/27/2026 |
|
P190006
S107 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
02/27/2026 |
|
P200015
S074 |
30-Day Notice | Edwards SAPIEN 3 Transcatheter Heart Valve System With Edwards Commander Delivery System |
Edwards Lifesciences, LLC |
02/27/2026 |
|
P220026
S015 |
30-Day Notice | Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter |
Medtronic, Inc. | 02/27/2026 |
|
P240011
S008 |
30-Day Notice | Altaviva™ | Medtronic Neuromodulation |
02/27/2026 |
|
P240022
S005 |
30-Day Notice | Evolysse™ Smooth; Evolysse™ Form | Symatese | 02/27/2026 |
|
P840001
S619 |
30-Day Notice | Master Restore™, Itrel™, Synergy Intellis™, Vanta™ And Inceptiv™ Spinal Cord Stimulation Systems And Pisces™, Specify™, |
Medtronic Neuromodulation |
02/27/2026 |
|
P960009
S530 |
30-Day Notice | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ |
Medtronic, Inc. | 02/27/2026 |
|
P970004
S445 |
30-Day Notice | InterStim™ Therapy System, Verify™ Evaluation System |
Medtronic Neuromodulation |
02/27/2026 |
|
P990056
S045 |
30-Day Notice | Elecsys Total PSA Assay | Roche Diagnostics Corp. | 02/27/2026 |
|
P010019
S086 |
30-Day Notice | Air Optix Plus Hydraglyde (lotrafilcon B) Spherical And Multifocal Soft Contact Lenses For Extended Wear |
Alcon Laboratories, Inc. | 02/26/2026 |
|
P050027
S035 |
Special (Immediate Track) |
Photodynamic Diagnostic D-Light C (PDD) System |
KARL STORZ Endoscopy-America, Inc. |
02/26/2026 |
|
P130005
S050 |
30-Day Notice | Diamondback 360™ Coronary Orbital Atherectomy System; Diamondback 360 Precision™ Coronary Orbital Atherectomy System |
Cardiovascular Systems, Inc. |
02/26/2026 |
|
P130021
S182 |
30-Day Notice | CoreValve EnVeo Pro Delivery Catheter System; Evolut PRO+ Delivery Catheter System; Evolut FX Delivery Catheter System |
Medtronic, Inc. | 02/26/2026 |
|
P150046
S005 |
Real-Time Process | Nevisense | Scibase AB | 02/26/2026 |
|
P210007
S008 |
Normal 180 Day Track | Vivistim® Paired VNS System | MicroTransponder, Inc. | 02/26/2026 |
|
P240035
S005 |
30-Day Notice | ETHIZIA Hemostatic Patch | Ethicon, Inc. | 02/26/2026 |
| P250028 | Original | Synergy Disc | Synergy Spine Solutions, Inc. |
02/26/2026 |
|
P890055
S092 |
Real-Time Process | Lntera 3000 Hepatic Artery Infusion Pump |
Intera Oncology | 02/26/2026 |
|
P000053
S141 |
30-Day Notice | AMS 800™ Artificial Urinary Sphincter (AUS) |
Boston Scientific Corp | 02/25/2026 |
|
P100009
S082 |
Real-Time Process | MitraClip™ G5 Delivery System (CDS0801-NT, CDS0801-NTW, CDS0801-XT, CDS0801-XTW) |
Abbott Medical | 02/25/2026 |
|
P100034
S043 |
30-Day Notice | Optune Gio® | Novocure, GmbH | 02/25/2026 |
|
P180046
S108 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
02/25/2026 |
|
P190006
S108 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
02/25/2026 |
|
P230007
S019 |
Real-Time Process | TriClip™ G5 Delivery System (TCDS0801-NT, TCDS0801-NTW, TCDS0801-XT, TCDS0801-XTW) |
Abbott Medical | 02/25/2026 |
|
P230042
S007 |
30-Day Notice | Optune Lua® | Novocure, GmbH | 02/25/2026 |
|
P900033
S116 |
30-Day Notice | INTEGRA ® Dermal Regeneration Template; Integra® Meshed Dermal Regeneration Template; Integra® Omnigraft Dermal Regenera |
Integra Lifesciences Corp. |
02/25/2026 |
|
P000054
S076 |
30-Day Notice | INFUSE Bone Graft | Medtronic Sofamor Danek USA, Inc. |
02/24/2026 |
|
P000058
S097 |
30-Day Notice | INFUSE Bone Graft/Medtronic Interbody Fusion Device |
Medtronic Sofamor Danek USA, Inc. |
02/24/2026 |
|
P050053
S067 |
30-Day Notice | INFUSE Bone Graft | Medtronic, Inc. | 02/24/2026 |
|
P080025
S335 |
Real-Time Process | InterStim™ Therapy System, Verify™ Evaluation System (SNS Bowel Programming Systems A510, A511, A520, A521) |
Medtronic Neuromodulation |
02/24/2026 |
|
P180046
S106 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
02/24/2026 |
|
P190006
S106 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
02/24/2026 |
|
P200049
S016 |
30-Day Notice | Amplatzer™ Amulet™ Left Atrial Appendage Occluder (Amulet) |
Abbott Medical | 02/24/2026 |
|
P230003
S012 |
30-Day Notice | Alinity M HR HPV | Abbott Molecular, Inc. | 02/24/2026 |
|
P230040
S028 |
30-Day Notice | Cordella Pulmonary Artery Sensor System (CorPASS) |
Endotronix, Inc. | 02/24/2026 |
|
P240035
S006 |
30-Day Notice | ETHIZIA™ Hemostatic Patch | Ethicon, Inc. | 02/24/2026 |
|
P970004
S440 |
Real-Time Process | InterStim™ Therapy System, Verify™ Evaluation System (SNS Urinary Programming Systems A510, A511, A520, A521) |
Medtronic Neuromodulation |
02/24/2026 |
|
P130008
S135 |
30-Day Notice | Model 3028 Connector Block Laser Weld Inspection Update |
Inspire Medical Systems | 02/23/2026 |
|
P150033
S222 |
30-Day Notice | Miera AV TPS; Miera TPS | Medtronic, Inc. | 02/23/2026 |
|
P150035
S034 |
Normal 180 Day Track No User Fee |
Aveir DR Delivery Catheter (LSCD201) | Abbott Medical | 02/23/2026 |
|
P160026
S065 |
Real-Time Process | LIFEPAK® 35 Monitor/defibrillator | Physio-Control, Inc. | 02/23/2026 |
|
P910007
S068 |
30-Day Notice | ARCHITECT Total PSA / Alinity I Total PSA (LN 6C06/07P92) |
Abbott Laboratories | 02/23/2026 |
|
P170030
S060 |
30-Day Notice | Orsiro Mission Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System |
Biotronik, Inc. | 02/22/2026 |
| P250023 | Original | Allurion™ Gastric Balloon System | Allurion Technologies, Inc. |
02/20/2026 |
|
P030011
S097 |
Real-Time Process | SynCardia Total Artificial Heart (STAH) System |
Syncardia Systems, LLC | 02/20/2026 |
|
P050006
S117 |
30-Day Notice | GORE® CARDIOFORM ASD Occluder; GORE® CARDIOFORM Septal Occluder |
W.L. Gore & Associates, Inc. |
02/20/2026 |
|
P060001
S055 |
30-Day Notice | Protege™ RX Carotid Stent System; Protege™ GPS™ Self-Expanding Peripheral Stent System |
Medtronic Vascular, Inc. | 02/20/2026 |
|
P100018
S052 |
Real-Time Process | PIPELINE EMBOLIZATION DEVICE | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
02/20/2026 |
|
P100026
S103 |
30-Day Notice | NeuroPace® RNS® System | NeuroPace, Inc. | 02/20/2026 |
|
P110023
S064 |
30-Day Notice | EverFlex™ Self-Expanding Peripheral Stent System; EverFlex™ Self-Expanding Peripheral Stent With Entrust™ Delivery Syste |
Medtronic Vascular, Inc. | 02/20/2026 |
|
P110042
S203 |
Normal 180 Day Track | EMBLEM S-ICD Electrode (Lead) | Boston Scientific Corporation |
02/20/2026 |
|
P120017
S039 |
30-Day Notice | Myocardial Pacing Lead | Medtronic, Inc. | 02/20/2026 |
|
P170030
S059 |
30-Day Notice | Orsiro Mission Sirolimus Eluting Coronary Stent System, Synsiro Pro Sirolimus Eluting Coronary Stent System |
Biotronik, Inc. | 02/20/2026 |
|
P200039
S019 |
Normal 180 Day Track | Shockwave Intravascular Lithotripsy (IVL) System With Shockwave C2 Aero Fly Coronary Intravascular Lithotripsy (IVL) Cat |
Shockwave Medical, Inc. | 02/20/2026 |
|
P240012
S005 |
Normal 180 Day Track No User Fee |
AeroPace® System | Lungpacer Medical USA, Inc. |
02/20/2026 |
|
P240029
S001 |
30-Day Notice | CGuard™ Prime Carotid Stent System | Inspiremd, Ltd. | 02/20/2026 |
|
P910073
S185 |
Normal 180 Day Track No User Fee |
ENDOTAK RELIANCE™ / RELIANCE 4-FRONT™ Pace/sense Defibrillation Leads |
Boston Scientific | 02/20/2026 |
|
P020016
S013 |
30-Day Notice | Total Temporomandibular Joint Replacement System |
Biomet Microfixation, Inc. |
02/19/2026 |
|
P030054
S435 |
135 Review Track For 30-Day Notice |
Quartet; QuickFlex Micro | Abbott Medical | 02/19/2026 |
|
P150035
S026 |
135 Review Track For 30-Day Notice |
Aveir™ VR Leadless Pacemaker, Aveir™ Leadless Pacemaker (Right Ventricular) |
Abbott Medical | 02/19/2026 |
|
P180003
S014 |
30-Day Notice | BioMimics 3D® Vascular Stent System | Veryan Medical, Ltd. | 02/19/2026 |
|
P190015
S029 |
30-Day Notice | TREO® Abdominal Stent-Graft System | Bolton Medical, Inc. | 02/19/2026 |
|
P190018
S047 |
Real-Time Process | Clareon TruPlus Aspheric Hydrophobic Acrylic Intraocular Lens (IOL); Clareon TruPlus Toric Aspheric Hydrophobic Acrylic |
Alcon Laboratories, LLC | 02/19/2026 |
|
P200045
S022 |
30-Day Notice | RelayPro Thoracic Stent-Graft System | Bolton Medical, Inc. | 02/19/2026 |
|
P250019
S001 |
Normal 180 Day Track No User Fee |
SAPIEN M3 Transcatheter Mitral Valve Replacement System |
Edwards Lifesciences, LLC |
02/19/2026 |
|
P840001
S615 |
Real-Time Process | Master Restore, Itrel, Synerg, Intellis, Vanta And Inceptiv Spinal Cord Stimulation Systems And Pisces, Specify, And Vec |
Medtronic Neuromodulation |
02/19/2026 |
|
P950022
S148 |
135 Review Track For 30-Day Notice |
Durata, Optisure | Abbott Medical | 02/19/2026 |
|
P960013
S129 |
135 Review Track For 30-Day Notice |
Tendril STS; OptiSense; UltiPace | Abbott Medical | 02/19/2026 |
|
P960030
S080 |
135 Review Track For 30-Day Notice |
IsoFlex | Abbott Medical | 02/19/2026 |
|
P030052
S030 |
30-Day Notice | UroVysion Bladder Cancer Kit | Abbott Molecular | 02/18/2026 |
|
P060040
S121 |
Real-Time Process | HeartMate II Left Ventricular Assist System (LVAS) |
Abbott Medical | 02/18/2026 |
|
P100047
S234 |
Normal 180 Day Track | HeartWare® HVAD System | Medtronic | 02/18/2026 |
|
P110012
S023 |
30-Day Notice | Vysis ALK Break Apart FISH Probe Kit | Abbott Molecular, Inc. | 02/18/2026 |
|
P130005
S049 |
30-Day Notice | DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM |
Cardiovascular Systems, Inc. |
02/18/2026 |
|
P150041
S008 |
30-Day Notice | Vysis CLL FISH Probe Kit | Abbott Molecular, Inc. | 02/18/2026 |
|
P160054
S115 |
Real-Time Process | HeartMate 3™ Left Ventricular Assist System (LVAS) |
Abbott Medical | 02/18/2026 |
|
P170038
S028 |
30-Day Notice | CentriMag Circulatory Support System | Abbott | 02/18/2026 |
|
P190015
S027 |
Real-Time Process | TREO® Abdominal Stent-Graft System | Bolton Medical, Inc. | 02/18/2026 |
|
P230044
S003 |
30-Day Notice | Alfapump System | Sequana Medical NV | 02/18/2026 |
|
P240039
S002 |
135 Review Track For 30-Day Notice |
SetPoint System | SetPoint Medical | 02/18/2026 |
|
P240044
S002 |
Real-Time Process | Globe Catheter (601-01000) | Kardium, Inc. | 02/18/2026 |
|
P180035
S034 |
30-Day Notice | MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses For Daily Wear |
CooperVision, Inc. | 02/17/2026 |
|
P220030
S010 |
30-Day Notice | UNIPURE C3F8 Ophthalmic Gas In The UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas In The UNIPEXY Gas Delivery |
Alcon Research, LLC | 02/17/2026 |
|
P230012
S010 |
30-Day Notice | UNIPURE SF6 Ophthalmic Gas In The UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas In The UNIPEXY Gas Delivery Sy |
Alcon Research, LLC | 02/17/2026 |
|
P230017
S009 |
Normal 180 Day Track | PulseSelect™ Pulsed Field Ablation (PFA) System |
Medtronic, Inc. | 02/17/2026 |
|
P230040
S027 |
30-Day Notice | Cordella Pulmonary Artery Sensor System (CorPASS) |
Endotronix, Inc. | 02/17/2026 |
|
P000058
S096 |
Panel Track | Infuse Bone Graft | Medtronic Sofamor Danek USA, Inc. |
02/13/2026 |
|
P010012
S602 |
30-Day Notice | ACUITY™ X4 Straight/ Model 4671; ACUITY X4 Straight/ Model 4672; ACUITY X4 Spiral S/ Model 4674; ACUITY X4 Spiral S/ Mod |
Boston Scientific Corp | 02/13/2026 |
|
P030054
S441 |
30-Day Notice | Avant (CDHFA700Q, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800T CDHFA600Q, CDHFA600T); Gallant (CDHFA500Q, CDHFA500T); |
Abbott Medical | 02/13/2026 |
|
P110019
S140 |
30-Day Notice | XIENCE Alpine Everolimus Eluting Coronary Stent System; XIENCE Sierra Everolimus Eluting Coronary Stent System; XIENCE P |
Abbott Vascular | 02/13/2026 |
|
P110042
S208 |
30-Day Notice | EMBLEM™ S-ICD/ Model 3501 | Boston Scientific Corporation |
02/13/2026 |
|
P140002
S033 |
30-Day Notice | MISAGO® RX Self-expanding Peripheral Stent |
Terumo Medical Corporation |
02/13/2026 |
|
P140010
S101 |
30-Day Notice | IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
Medtronic, Inc. | 02/13/2026 |
|
P150012
S179 |
30-Day Notice | INGEVITY™ MRI/ Model 7731; INGEVITY™ MRI/ Model 7732; INGEVITY™ MRI/ Model 7735; INGEVITY™ MRI/ Model 7736; INGEVITY™ MR |
Boston Scientific | 02/13/2026 |
|
P190008
S046 |
30-Day Notice | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
Medtronic Vascular, Inc. | 02/13/2026 |
|
P230040
S026 |
Special (Immediate Track) |
Cordella Pulmonary Artery Sensor System (CorPASS) |
Endotronix, Inc. | 02/13/2026 |
|
P830055
S358 |
30-Day Notice | LCS® Total Knee System | Depuy, Inc. | 02/13/2026 |
|
P830055
S361 |
30-Day Notice | LCS® Total Knee System | Depuy, Inc. | 02/13/2026 |
|
P840001
S609 |
135 Review Track For 30-Day Notice |
Restore™, Itrel™, Synergy™, Intellis™, Vanta™ And Inceptiv™ Spinal Cord Stimulation Systems And Pisces™, Specify™, And V |
Medtronic Neuromodulation |
02/13/2026 |
|
P910023
S483 |
30-Day Notice | Avant (CDVRA700Q, CDVRA700T); Neutrino NxT (CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T); Gallant (CDVRA500Q, CDVRA500T); |
Abbott Medical | 02/13/2026 |
|
P910073
S186 |
30-Day Notice | RELIANCE 4-FRONT™/model 0636; RELIANCE 4-FRONT/ Model 0662; RELIANCE 4-FRONT/ Model 0663 00802526592805 P910073; RELIANC |
Boston Scientific | 02/13/2026 |
|
P920015
S303 |
30-Day Notice | Sprint Quattro Lead (6935M, 6947); Sprint Quattro Lead (6935, 6947M) |
Medtronic, Inc. | 02/13/2026 |
|
P950037
S280 |
Normal 180 Day Track | Solia CSP S 53; Solia CSP S 60 | Biotronik, Inc. | 02/12/2026 |
|
P010015
S580 |
30-Day Notice | Consulta CRT-P C4TR01 Syncra CRT-P C2TR01 |
Medtronic, Inc. | 02/12/2026 |
|
P010031
S916 |
30-Day Notice | Amplia MRI CRT-D DTMB1D1, DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D1, DTBC1D4 Brava Quad CRT-D D |
Medtronic Cardiac Rhythm Disease Management |
02/12/2026 |
|
P020024
S072 |
30-Day Notice | Amplatzer™ Piccolo™ Occluder | Abbott Medical | 02/12/2026 |
|
P080025
S339 |
30-Day Notice | SNS Bowel Neurostimulator Models 97800, 97810; SNS Bowel Screening Trialing System Model 3531 |
Medtronic Neuromodulation |
02/12/2026 |
|
P120008
S031 |
30-Day Notice | ARCHITECT AFP; Alinity I AFP (LN 3P36/07P90) |
Abbott Laboratories | 02/12/2026 |
|
P130013
S083 |
30-Day Notice | WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device With Delivery System |
Boston Scientific Corp | 02/12/2026 |
|
P130021
S179 |
135 Review Track For 30-Day Notice |
Evolut PRO, PRO+, FX, FX+ | Medtronic, Inc. | 02/12/2026 |
|
P140013
S018 |
30-Day Notice | Minerva Endometrial Ablation System | Axora Medical, Inc. | 02/12/2026 |
|
P140017
S033 |
135 Review Track For 30-Day Notice |
Melody Transcatheter Pulmonary Valve | Medtronic, Inc. | 02/12/2026 |
|
P140031
S199 |
30-Day Notice | Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29, 9750CM20, 9750CM23, 9750CM26) |
Edwards Lifesciences, LLC |
02/12/2026 |
|
P160037
S026 |
30-Day Notice | BD FOX™ PCR Extraction Tubes; BD Onclarity™ HPV Assay |
Becton, Dickinson and Company |
02/12/2026 |
|
P170006
S040 |
135 Review Track For 30-Day Notice |
Avalus Bioprostheses | Medtronic, Inc. | 02/12/2026 |
|
P190009
S012 |
30-Day Notice | OPRA Implant System | Integrum AB | 02/12/2026 |
|
P200015
S073 |
30-Day Notice | Edwards Commander Delivery System (9600LDS20, 9600LDS23 9600LDS26, 9600LDS29) |
Edwards Lifesciences, LLC |
02/12/2026 |
|
P200046
S045 |
135 Review Track For 30-Day Notice |
Harmony Transcatheter Pulmonary Valve |
Medtronic, Inc. | 02/12/2026 |
|
P200049
S015 |
30-Day Notice | Amplatzer™ Amulet™ Left Atrial Appendage Occluder |
Abbott Medical | 02/12/2026 |
|
P220012
S067 |
30-Day Notice | Aurora EV ICD DVEA3E4 | Medtronic, Inc. | 02/12/2026 |
| P220031 | Original | LimiFlex Dynamic Sagittal Tether | Empirical Spine, Inc. | 02/12/2026 |
|
P230013
S023 |
30-Day Notice | Edwards EVOQUE Tricuspid Valve Replacement System (9850TDS) |
Edwards Lifesciences, LLC |
02/12/2026 |
|
P230021
S003 |
Normal 180 Day Track No User Fee |
Duo Venous Stent System | Philips Image Guided Therapy Corporation |
02/12/2026 |
|
P240006
S014 |
Normal 180 Day Track No User Fee |
VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; Ngen™ Pump) |
Biosense Webster, Inc. | 02/12/2026 |
|
P240011
S006 |
30-Day Notice | Altaviva Model P7850N | Medtronic Neuromodulation |
02/12/2026 |
|
P250003
S004 |
Special (Immediate Track) |
Embrace™ Hydrogel Embolic System (HES) |
Instylla, Inc. | 02/12/2026 |
|
P830055
S357 |
Special (Immediate Track) |
LCS® Total Knee System | Depuy, Inc. | 02/12/2026 |
|
P840001
S617 |
30-Day Notice | External Neurostimulator (ENS) Model 97725; Intellis Model 97716; Intellis™ Model 97715; SCS Implantable Neurostimulator |
Medtronic Neuromodulation |
02/12/2026 |
|
P860004
S456 |
30-Day Notice | Drug Delivery Infusion Pump Model 8667 |
Medtronic, Inc. | 02/12/2026 |
|
P910007
S067 |
30-Day Notice | ARCHITECT Total PSA; Alinity I Total PSA (LN 6C06/07P92) |
Abbott Laboratories | 02/12/2026 |
|
P960009
S528 |
30-Day Notice | DBS Implantable Neurostimulator Models B35200, B35300; DBS Implantable Neurostimulators Activa Family Models 37601, 3760 |
Medtronic, Inc. | 02/12/2026 |
|
P970004
S444 |
30-Day Notice | SNS Urinary Neurostimulator Models 97800, 97810; SNS Urinary Screening Trialing Systems Model 3531 |
Medtronic Neuromodulation |
02/12/2026 |
|
P970031
S078 |
135 Review Track For 30-Day Notice |
Freestyle Bioprosthesis | Medtronic, Inc. | 02/12/2026 |
|
P980007
S056 |
30-Day Notice | ARCHITECT Free PSA; Alinity I Free PSA (LN 6C07/07P93) |
Abbott Laboratories | 02/12/2026 |
|
P980016
S949 |
30-Day Notice | Evera MRI DF-1 ICD DDMB1D1, DDMC3D1, DVMB1D1, DVMC3D1 Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DD |
Medtronic Cardiac Rhythm Disease Management |
02/12/2026 |
|
P980035
S832 |
30-Day Notice | Advisa DR IPG A4DR01 Advisa DR MRI IPG A2DR01 Advisa SR MRI IPG A3SR01 |
Medtronic, Inc. | 02/12/2026 |
|
P980043
S086 |
135 Review Track For 30-Day Notice |
Hancock II Bioprosthesis | Medtronic, Inc. | 02/12/2026 |
|
P990064
S096 |
135 Review Track For 30-Day Notice |
Mosaic Bioprosthesis | Medtronic, Inc. | 02/12/2026 |
