| PMA Number | Suppl. Type | Device Name | Applicant | Decision Date |
|---|---|---|---|---|
|
N12159
S127 |
30-Day Notice | SURGICEL® Absorbable Hemostats | Ethicon, Inc. | 12/12/2025 |
|
P040020
S117 |
30-Day Notice | AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses |
Alcon Research, Ltd. | 12/12/2025 |
|
P040047
S079 |
30-Day Notice | COAPTITE | Merz North America, Inc. | 12/12/2025 |
|
P050037
S148 |
30-Day Notice | RADIESSE 1.3CC AND 0.3CC | Merz North America, Inc. | 12/12/2025 |
|
P050052
S173 |
30-Day Notice | RADIESSE INJECTABLE IMPLANT | Merz North America, Inc. | 12/12/2025 |
|
P130013
S080 |
30-Day Notice | WATCHMAN FLX™ Left Atrial Appendage (LAA) Closure Device With Delivery System; WATCHMAN FLX™ Pro Left Atrial Appendage ( |
Boston Scientific Corp | 12/12/2025 |
|
P140002
S031 |
Real-Time Process | MISAGO® RX Self-expanding Peripheral Stent |
Terumomedical Corporation |
12/12/2025 |
|
P190018
S045 |
30-Day Notice | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) And Clareon PanOptix Hydrophobic Acrylic IOL |
Alcon Laboratories, LLC | 12/12/2025 |
|
P200026
S015 |
Special (Immediate Track) |
Abre Venous Self-expanding Stent System |
Medtronic Vascular, Inc. | 12/12/2025 |
|
P220029
S004 |
30-Day Notice | Optilume™ BPH Catheter System | Urotronic, Inc. | 12/12/2025 |
|
P880047
S068 |
30-Day Notice | INTERCEED™ Absorbable Adhesion Barrier |
Ethicon, Inc. | 12/12/2025 |
|
P930014
S159 |
30-Day Notice | AcrySof Posterior Chamber Intraocular Lens And Delivery Systems |
Alcon Laboratories, Inc. | 12/12/2025 |
|
P010030
S198 |
30-Day Notice | LifeVest® Wearable Defibrillator | Zoll Manufacturing Corporation |
12/11/2025 |
|
P080011
S193 |
30-Day Notice | Biofinity XR Toric And Biofinity Toric Multifocal (Comfilcon A) Soft (Hydrophilic) Contact Lenses For Extended Wear |
CooperVision, Inc. | 12/11/2025 |
|
P160017
S125 |
Panel Track | MiniMed 780G System | Medtronic Minimed, Inc. | 12/11/2025 |
|
P240001
S001 |
Normal 180 Day Track | PearlMatrix™ P-15 Peptide Enhanced Bone Graft (PearlMatrix™ Bone Graft) |
Cerapedics, Inc. | 12/11/2025 |
|
P240023
S004 |
Normal 180 Day Track No User Fee |
WRAPSODY® Cell-Impermeable Endoprosthesis |
Merit Medical Systems, Inc. |
12/11/2025 |
| P250007 | Original | Zenflow Spring® Implant And Delivery System |
Zenflow, Inc. | 12/11/2025 |
|
P830055
S354 |
30-Day Notice | LCS® Total Knee System | Depuy, Inc. | 12/11/2025 |
|
P890023
S056 |
30-Day Notice | Biornedics 55 Asphere And Biornedies Torie (Ocuftlcon D) Soft (Hydrophilic) Contact Lenses For Extended Wear |
The Cooper Companies | 12/11/2025 |
|
P030016
S049 |
Normal 180 Day Track No User Fee |
Visian® Toric Implantable Collamer® Lens (TICL) |
Staar Surgical Company | 12/10/2025 |
|
P030017
S389 |
Real-Time Process | WaveWriter Alpha™ Prime Spinal Cord Stimulation (SCS) Systems |
Boston Scientific Corp | 12/10/2025 |
|
P070008
S173 |
30-Day Notice | Sentus ProMRI OTW QP S-75; Sentus ProMRI OTW QP S-85; Sentus ProMRI OTW QP S-95; Sentus ProMRI OTW QP L-75; Sentus ProMR |
Biotronik, Inc. | 12/10/2025 |
|
P150031
S089 |
Real-Time Process | Vercise Genus™ Deep Brain Stimulation (DBS) Systems |
Boston Scientific Corp | 12/10/2025 |
|
P160017
S131 |
30-Day Notice | MiniMed 670G System MiniMed 770G System MiniMed 780G System |
Medtronic Minimed, Inc. | 12/10/2025 |
| P240043 | Original | DIAM™ Spinal Stabilization System |
Companion Spine France Sas |
12/10/2025 |
|
P250012
S005 |
30-Day Notice | Simplera Sync Sensor; Guardian 4 Sensor |
Medtronic Minimed, Inc. | 12/10/2025 |
|
P950037
S281 |
30-Day Notice | Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53; Siello S 45; Sie |
Biotronik, Inc. | 12/10/2025 |
|
P010030
S197 |
Real-Time Process | LifeVest® Wearable Defibrillator | Zoll Manufacturing Corporation |
12/09/2025 |
|
P040038
S048 |
Normal 180 Day Track No User Fee |
XACT® Carotid Stent System | Abbott Vascular, Inc. | 12/09/2025 |
|
P050007
S047 |
Normal 180 Day Track No User Fee |
StarClose SE® Vascular Surgical System |
Abbott Vascular Devices | 12/09/2025 |
|
P070026
S123 |
30-Day Notice | Ceramax Ceramic Hip System | DePuy Orthopaedics, Inc. | 12/09/2025 |
|
P120020
S034 |
Normal 180 Day Track No User Fee |
Supera™ Peripheral Stent System | Abbott Vascular (Idef Technologies Inc) |
12/09/2025 |
|
P160022
S048 |
Real-Time Process | ZOLL Zenix Monitor/Defibrillator; ZOLL Zenix Multi-function Cable; ZOLL Zenix CPR Complete Electrodes; ZOLL OneStep Paci |
Zoll Medical Corporation | 12/09/2025 |
| P250011 | Original | ProVee System For BPH | Proverum, Ltd. | 12/09/2025 |
|
P830055
S353 |
30-Day Notice | LCS® Total Knee System | Depuy, Inc. | 12/09/2025 |
|
P950022
S151 |
30-Day Notice | Durata Leads; Optisure Leads | Abbott Medical | 12/09/2025 |
|
P960013
S132 |
30-Day Notice | Tendril STS Leads; Ultipace Leads | Abbott Medical | 12/09/2025 |
|
P960043
S127 |
Normal 180 Day Track No User Fee |
Perclose ProGlide® Suture-Mediated Closure System; Prostar® XL Percutaneous Vascular Surgical System |
Abbott Vascular, Inc. | 12/09/2025 |
|
P030004
S035 |
Panel Track | Onyx Liquid Embolic System (LES) | Ev3 Neurovascular | 12/08/2025 |
|
P160007
S059 |
30-Day Notice | Simplera System | Medtronic Minimed | 12/08/2025 |
|
P160017
S134 |
30-Day Notice | MiniMed 780G System | Medtronic Minimed, Inc. | 12/08/2025 |
| P230024 | Original | Flow FL-100 | Flow Neuroscience AB | 12/08/2025 |
|
P250012
S007 |
30-Day Notice | Simplera Sync Sensor | Medtronic Minimed, Inc. | 12/08/2025 |
|
P960009
S524 |
Real-Time Process | Activa™ Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense™ |
Medtronic, Inc. | 12/08/2025 |
|
P080011
S191 |
Normal 180 Day Track No User Fee |
Sofmed® Breathables™ XW NEXT | CooperVision, Inc. | 12/05/2025 |
|
P150005
S090 |
Normal 180 Day Track | Intellagen™ Irrigation Tubing Set | Boston Scientific Corp | 12/05/2025 |
|
P160007
S057 |
30-Day Notice | Simplera System | Medtronic Minimed | 12/05/2025 |
|
P160017
S132 |
30-Day Notice | MiniMed 780G System | Medtronic Minimed, Inc. | 12/05/2025 |
|
P200030
S023 |
Real-Time Process | GORE® EXCLUDER® Conformable AAA Endoprosthesis |
W. L. Gore and Associates, Inc. |
12/05/2025 |
|
P250012
S006 |
30-Day Notice | Simplera Sync Sensor | Medtronic Minimed, Inc. | 12/05/2025 |
|
P020036
S058 |
30-Day Notice | S.M.A.R.T.® CONTROL® Nitinol Stent System |
Cordis US Corporation | 12/04/2025 |
|
P090022
S047 |
Normal 180 Day Track | Softec HD; Softec I; Softec HDO; Softec HDM |
Lenstec, Inc. | 12/04/2025 |
|
P120002
S033 |
30-Day Notice | S.M.A.R.T. And S.M.A.R.T.® CONTROL® Vascular Stent Systems |
Cordis US Corporation | 12/04/2025 |
|
P160026
S063 |
30-Day Notice | LIFEPAK® 35 Defibrillator/monitor | Physio-Control, Inc. | 12/04/2025 |
|
P170035
S019 |
30-Day Notice | Bausch + Lomb Ultra (Samfilcon A) Visibly Tinted (Soft) Contact Lenses |
Bausch and Lomb, Inc., | 12/04/2025 |
|
P200020
S010 |
Normal 180 Day Track | ClearView 3 | Lenstec, Inc. | 12/04/2025 |
|
P010015
S575 |
30-Day Notice | Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol |
Medtronic, Inc. | 12/03/2025 |
|
P010031
S907 |
30-Day Notice | Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D |
Medtronic Cardiac Rhythm Disease Management |
12/03/2025 |
|
P010031
S908 |
30-Day Notice | Amplia MRI CRT-D DTMB1D1, DTMB1D4, Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ NIK Brava CRT-D DTBC1D1 KRG, NIK Brava CRT-D D |
Medtronic Cardiac Rhythm Disease Management |
12/03/2025 |
|
P010031
S910 |
30-Day Notice | Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua |
Medtronic Cardiac Rhythm Disease Management |
12/03/2025 |
|
P150033
S219 |
30-Day Notice | Micra AV TPS MC1AVR1 PNJ Micra AV2 TPS MC2AVR1 PNJ Micra TPS MC1VR01 PNJ Micra VR2 TPS MC2VR01 |
Medtronic, Inc. | 12/03/2025 |
|
P220012
S060 |
30-Day Notice | Aurora EV ICD DVEA3E4 | Medtronic, Inc. | 12/03/2025 |
|
P220012
S062 |
30-Day Notice | Aurora EV ICD (DVEA3E4) | Medtronic, Inc. | 12/03/2025 |
|
P230020
S005 |
Normal 180 Day Track No User Fee |
Altius® Direct Electrical Nerve Stimulation System |
Neuros Medical, Inc. | 12/03/2025 |
| P240021 | Original | Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. |
12/03/2025 |
|
P890003
S483 |
30-Day Notice | CareLink SmartSync Device Manager Base 24970A |
Medtronic, Inc. | 12/03/2025 |
|
P980016
S940 |
30-Day Notice | Cobalt MRI ICD; Cobalt XT MRI ICD ; Crome MRI ICD |
Medtronic Cardiac Rhythm Disease Management |
12/03/2025 |
|
P980016
S941 |
30-Day Notice | Cobalt MRI ICD DVPB3D1, DDPB3D1, DDPB3D4, DVPB3D4 LWS, NVZ Cobalt XT MRI ICD DVPA2D1, DVPA2D4, DDPA2D1, DDPA2D4 LWS, NVZ |
Medtronic Cardiac Rhythm Disease Management |
12/03/2025 |
|
P980016
S943 |
30-Day Notice | Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I |
Medtronic Cardiac Rhythm Disease Management |
12/03/2025 |
|
P980035
S826 |
30-Day Notice | Adapta, Versa, Sensia IPG ADDRL1, ADDRS1, VEDR01, ADDR03, ADSR03, ADDR01, ADSR06, ADSR01, ADVDD01, SEDR01, ADDR06, SESR0 |
Medtronic, Inc. | 12/03/2025 |
|
P980035
S827 |
30-Day Notice | Adapta, Versa, Sensia IPG ADDR01, ADDRS1, ADSR03, SES01 LWP, NVZ Adapta, Versa, Sensia IPG SEDRL1 NVZ Adapta, Versa, Sen |
Medtronic, Inc. | 12/03/2025 |
|
P150033
S218 |
30-Day Notice | Micra A V2 TPS (MC2AVR1); Micra VR2 TPS (MC2VR01) |
Medtronic, Inc. | 12/02/2025 |
|
P170038
S025 |
Normal 180 Day Track No User Fee |
CentriMag™ Circulatory Support System |
Abbott | 12/01/2025 |
|
P950020
S147 |
30-Day Notice | WOLVERINE™ Coronary Cutting Balloon™ |
Boston Scientific Corp | 12/01/2025 |
| P200048 | Original | IsoPSA Assay | Cleveland Diagnostics, Inc. |
11/28/2025 |
|
BP140143
S930 |
Normal 180 Day Track | INTERCEPT(R) Blood Systerm For Platelets |
Cerus Corporation | 11/28/2025 |
|
P000025
S134 |
Panel Track | MED-EL CI System | Med-El Corp. | 11/26/2025 |
|
P080025
S334 |
Normal 180 Day Track No User Fee |
InterStim™ Therapy System, Verify™ Evaluation System |
Medtronic Neuromodulation |
11/26/2025 |
|
P240011
S003 |
Normal 180 Day Track No User Fee |
Altaviva™ | Medtronic Neuromodulation |
11/26/2025 |
|
P830055
S352 |
30-Day Notice | LCS® Total Knee System | Depuy, Inc. | 11/26/2025 |
|
P840001
S613 |
Normal 180 Day Track No User Fee |
Master Restore, Itrel, Synergy, Intellis, Vanta And Inceptiv Spinal Cord Stimulation Systems And Pisces, Specify, And Ve |
Medtronic Neuromodulation |
11/26/2025 |
|
P860004
S454 |
Normal 180 Day Track No User Fee |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
Medtronic, Inc. | 11/26/2025 |
|
P960009
S525 |
Normal 180 Day Track No User Fee |
Activa™ Deep Brain Stimulation Therapy System, Percept PC BrainSense™ |
Medtronic, Inc. | 11/26/2025 |
|
P970004
S439 |
Normal 180 Day Track No User Fee |
InterStim Therapy System, Verify Evaluation System |
Medtronic Neuromodulation |
11/26/2025 |
|
P060027
S106 |
Normal 180 Day Track | ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS |
Microport Crm, USA, Inc. | 11/25/2025 |
|
P130010
S002 |
Normal 180 Day Track | ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS |
Microport Crm, USA, Inc. | 11/25/2025 |
|
P970003
S251 |
Real-Time Process | VNS Therapy Model 3100 Programmer, VNS Therapy Model 2000 Programming Wand |
Liva Nova USA, Inc. | 11/25/2025 |
|
P980049
S146 |
Normal 180 Day Track | ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS |
Microport Crm, USA, Inc. | 11/25/2025 |
|
P150033
S217 |
Normal 180 Day Track No User Fee |
Micra Transcatheter Pacing Systems | Medtronic, Inc. | 11/25/2025 |
|
P180014
S013 |
Real-Time Process | XPS™ With Steen Solution™ Perfusate |
Xvivo Perfusion, Inc. | 11/25/2025 |
|
P230014
S004 |
Special (Immediate Track) |
Lumicell Direct Visualization System (DVS) |
Lumicell, Inc. | 11/25/2025 |
|
P230040
S024 |
30-Day Notice | CorPASS System | Endotronix, Inc. | 11/25/2025 |
|
P250003
S001 |
Real-Time Process | Embrace(TM) Hydrogel Embolic System | Instylla, Inc. | 11/25/2025 |
|
P200032
S003 |
Real-Time Process | Occlutech ASD Occluder; Occlutech Pistol Pusher (OPP); Occlutech ASD Occluder Procedure Pack |
Occlutech Holding AG | 11/24/2025 |
|
P080003
S011 |
Normal 180 Day Track No User Fee |
Envision Mammography Platform | Hologic, Inc. | 11/24/2025 |
|
P130017
S066 |
Real-Time Process | Cologuard® | Exact Sciences Corporation |
11/24/2025 |
|
P160021
S048 |
Normal 180 Day Track | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis |
W.L. Gore & Associates, Inc. |
11/24/2025 |
|
P160049
S027 |
Normal 180 Day Track | Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon |
The Spectranetics Corp. | 11/24/2025 |
|
P960009
S482 |
Panel Track | Medtronic DBS Therapy For Dystonia | Medtronic, Inc. | 11/22/2025 |
|
P010033
S051 |
Real-Time Process | QuantiFERON-TB Gold Plus Test | Qiagen | 11/21/2025 |
|
P130020
S005 |
Normal 180 Day Track | Senographe Pristina 3D | Ge Healthcare | 11/21/2025 |
|
P160026
S064 |
30-Day Notice | LIFEPAK® 35 Monitor/defibrillator | Physio-Control, Inc. | 11/21/2025 |
|
P160045
S051 |
Special (Immediate Track) |
Oncomine™ Dx Target Test | Life Technologies Corporation |
11/21/2025 |
|
P860003
S112 |
Real-Time Process | THERAKOS® CELLEX® Photopheresis System (CELLEX), THERAKOS® CELLEX® Photopheresis Procedural Kit (CLXUSA And CLXECP), THE |
Therakos Development Limited |
11/21/2025 |
|
P030054
S439 |
Normal 180 Day Track | Quartet™ And QuickFlex™ Μ Left Heart Leads |
Abbott Medical | 11/20/2025 |
|
P140033
S100 |
Normal 180 Day Track | Tendril™ MRI Pacing Leads / Assurity MRI, Endurity MRI, Zenex MRI, Zenus MRI Pacemakers |
Abbott Medical | 11/20/2025 |
|
P190009
S006 |
135 Review Track For 30-Day Notice |
OPRA Implant System, Abutment Component |
Integrum AB | 11/20/2025 |
|
P950022
S150 |
Normal 180 Day Track | Durata™ Defibrillation Leads | Abbott Medical | 11/20/2025 |
|
P960013
S131 |
Normal 180 Day Track | OptiSense™ Pacing Leads | Abbott Medical | 11/20/2025 |
|
P960030
S083 |
Normal 180 Day Track | IsoFlex™ Pacing Leads | Abbott Medical | 11/20/2025 |
|
P070004
S045 |
135 Review Track For 30-Day Notice |
Sientra Silicone Gel Breast Implants | Tiger Aesthetics Medical, LLC |
11/20/2025 |
|
P230019
S003 |
Normal 180 Day Track No User Fee |
MediBeacon® Transdermal GFR Measurement System (GFR) |
Medibeacon, Inc. | 11/20/2025 |
|
P240013
S018 |
30-Day Notice | Sphere-9 TM Mapping And Ablation Catheter |
Medtronic, Inc. | 11/20/2025 |
|
P030011
S093 |
Normal 180 Day Track | Total Artificial Heart | Syncardia Systems, LLC | 11/19/2025 |
|
P160045
S050 |
Normal 180 Day Track | Oncomine Dx Target Test | Life Technologies Corporation |
11/19/2025 |
|
P180036
S034 |
135 Review Track For 30-Day Notice |
OPTIMIZER SMART Mini IPG | Impulse Dynamics (Usa), Inc. |
11/19/2025 |
|
P230013
S019 |
Real-Time Process | EVOQUE Tricuspid Valve Replacement System |
Edwards Lifesciences, LLC |
11/19/2025 |
|
P230022
S004 |
Normal 180 Day Track No User Fee |
Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati |
Element Science, Inc. | 11/19/2025 |
|
P230021
S002 |
Normal 180 Day Track No User Fee |
Duo Venous Stent System | Philips Image Guided Therapy Corporation |
11/18/2025 |
|
P230022
S002 |
Real-Time Process | Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class |
Element Science, Inc. | 11/18/2025 |
|
P990075
S065 |
135 Review Track For 30-Day Notice |
MENTOR™ Saline-Filled And SPECTRUM™ Breast Implants |
Mentor Worldwide, LLC | 11/18/2025 |
|
P030016
S048 |
Normal 180 Day Track | VISIAN ICL (IMPLANTABLE COLLAMER LENS) |
Staar Surgical Company | 11/14/2025 |
|
P200002
S013 |
Real-Time Process | EPi-Sense ST Coagulation System | Atricure, Inc. | 11/14/2025 |
|
P840001
S610 |
Normal 180 Day Track | Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ And Inceptiv™ Spinal Cord Stimulation Systems And Pisces™, Specify™ |
Medtronic Neuromodulation |
11/13/2025 |
|
P860004
S451 |
Normal 180 Day Track | SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters |
Medtronic, Inc. | 11/13/2025 |
|
P960009
S521 |
Normal 180 Day Track | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ |
Medtronic, Inc. | 11/13/2025 |
|
P990009
S077 |
30-Day Notice | Floseal Hemostatic Matrix, Floseal With Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma |
Baxter Healthcare Corp | 11/13/2025 |
|
P200007
S001 |
135 Review Track For 30-Day Notice |
HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads |
Graphic Controls D.B.A. Vermed |
11/12/2025 |
|
BP170154
S039 |
Special Supplement | ID CORE XT | Progenika Biopharma, S.A. |
11/12/2025 |
|
P100045
S087 |
Real-Time Process | CardioMEMS™ HF System (Merlin.net PCN HF Portal (Model MN6000) And CardioMEMS Backend Web Application (Model CM4000)) |
Abbott Medical | 11/10/2025 |
|
P170006
S038 |
Real-Time Process | Avalus Bioprosthesis, Avalus Ultra Bioprosthesis |
Medtronic, Inc. | 11/10/2025 |
|
P970031
S076 |
Real-Time Process | Freestyle Bioprosthesis | Medtronic, Inc. | 11/10/2025 |
|
P980043
S084 |
Real-Time Process | Hancock II Bioprosthesis | Medtronic, Inc. | 11/10/2025 |
|
P990064
S093 |
Real-Time Process | Mosaic Bioprosthesis | Medtronic, Inc. | 11/10/2025 |
|
P190002
S045 |
Real-Time Process | Saluda Medical Evoke® SCS System | Saluda Medical Pty. , Ltd. |
11/08/2025 |
|
P010032
S243 |
Normal 180 Day Track | Spinal Cord Stimulation (SCS) Neurostimulation System |
Abbott Medical | 11/07/2025 |
|
P140009
S124 |
Normal 180 Day Track | Deep Brain Stimulation (DBS) Neurostimulation System |
Abbott Medical | 11/07/2025 |
|
P150004
S090 |
Normal 180 Day Track | Dorsal Root Ganglion (DRG) Neurostimulation System |
Abbott Medical | 11/07/2025 |
|
P060001
S052 |
Real-Time Process | Protégé GPS Self-expanding Peripheral Stent System |
Medtronic Vascular, Inc. | 11/07/2025 |
|
P100044
S058 |
Real-Time Process | Propel Contour Sinus Implant | Intersect Ent. | 11/07/2025 |
|
P110023
S061 |
Real-Time Process | EverFlex Self-expanding Peripheral Stent System (EverFlex) |
Medtronic Vascular, Inc. | 11/07/2025 |
|
P240027
S004 |
Real-Time Process | SpineSeal™ Spine Sealant | Pramand, LLC | 11/07/2025 |
|
P130014
S021 |
135 Review Track For 30-Day Notice |
Adherus AutoSpray Dural Sealant | Stryker Leibinger GmbH & Co KG |
11/06/2025 |
|
P130013
S081 |
Special (Immediate Track) |
WATCHMAN FLX Pro Left Atrial Appendage Closure Device With Delivery System; WATCHMAN FLX Left Atrial Appendage Closure D |
Boston Scientific Corp | 11/06/2025 |
|
P170018
S023 |
Real-Time Process | LIFEPAK® CR2 Automated External Defibrillator |
Physio-Control, Inc. | 11/06/2025 |
|
P240024
S002 |
Normal 180 Day Track No User Fee |
Genio® System 2.1 | Nyxoah S.A. | 11/06/2025 |
| P240026 | Original | OncoMate® MSI Dx Analysis System | Promega Corporation | 11/05/2025 |
|
P040024
S142 |
Panel Track | Restylane® Lyft With Lidocaine | Q-Med AB | 11/04/2025 |
|
P080025
S321 |
Real-Time Process | Nterstim™ Therapy System, Verify™ Evaluation System |
Medtronic Neuromodulation |
11/04/2025 |
|
P960009
S508 |
Real-Time Process | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ |
Medtronic, Inc. | 11/04/2025 |
|
P970004
S426 |
Real-Time Process | InterStim™ Therapy System, Verify™ Evaluation System |
Medtronic Neuromodulation |
11/04/2025 |
|
P160054
S112 |
Real-Time Process | HeartMate 3™ Left Ventricular Assist System (LVAS) |
Abbott Medical | 11/04/2025 |
|
P840001
S596 |
Real-Time Process | Master Restore™, Itrel™, Synergy Intellis™, Vanta™ And Inceptiv™ Spinal Cord Stimulation Systems And Pisces™, Specify™, |
Medtronic Neuromodulation |
11/04/2025 |
|
N12159
S122 |
Real-Time Process | SURGICEL® Absorbable Hemostats | Ethicon, Inc. | 11/04/2025 |
|
P980041
S051 |
Normal 180 Day Track | Access AFP (on DxI 9000 Analyzer) | Beckman Coulter, Inc. | 11/03/2025 |
|
P180027
S013 |
Normal 180 Day Track No User Fee |
Flow Re-Direction Endoluminal Device (FRED®) System |
Microvention, Inc. | 11/02/2025 |
|
P230013
S013 |
Normal 180 Day Track | Edwards EVOQUE Tricuspid Valve Replacement System |
Edwards Lifesciences, LLC |
10/31/2025 |
|
P010007
S024 |
30-Day Notice | IMMULITE 2000 AFP | Siemens Healthcare Diagnostics, Inc. |
10/30/2025 |
|
P040021
S060 |
30-Day Notice | Epic™, Epic™ Supra, Epic™ Plus, Epic™ Plus Supra And Epic™ Max Stented Tissue Valve |
Abbott, Medical | 10/30/2025 |
|
P060005
S023 |
30-Day Notice | IMMULITE 2000 Free PSA | Siemens Medical Solutions Diagnostics Limited |
10/30/2025 |
|
P170006
S041 |
30-Day Notice | Avalus Bioprosthesis | Medtronic, Inc. | 10/30/2025 |
|
P220013
S023 |
30-Day Notice | TactiFlex™ Ablation Catheter, Sensor Enabled ™ (TactiFlex SE) |
Abbott, Medical | 10/30/2025 |
|
P230009
S009 |
30-Day Notice | Shield | Guardant Health, Inc. | 10/30/2025 |
|
P240036
S003 |
30-Day Notice | OmniaSecure™ MRI SureScan™ Lead Model 3930M |
Medtronic, Inc. | 10/30/2025 |
|
P890003
S481 |
Normal 180 Day Track No User Fee |
SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 |
Medtronic, Inc. | 10/30/2025 |
|
P930027
S037 |
30-Day Notice | IMMULITE 2000 PSA | Siemens Healthcare Diagnostics, Inc. |
10/30/2025 |
|
P110002
S037 |
Normal 180 Day Track No User Fee |
LDR Spine Mobi-C® Cervical Disc Prosthesis |
Zimmer Biomet Spine, Inc. |
10/29/2025 |
|
P110009
S037 |
Normal 180 Day Track No User Fee |
LDR Spine Mobi-C® Cervical Disc Prosthesis |
Zimmer Biomet Spine, Inc. |
10/29/2025 |
|
P150003
S110 |
30-Day Notice | SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System |
Boston Scientific Corporation |
10/29/2025 |
|
P170027
S020 |
30-Day Notice | TherOx Downstream System | Zoll Circulation, Inc. | 10/29/2025 |
|
P200041
S009 |
30-Day Notice | Scoreflex NC Scoring PTCA Catheter | Orbusneich Medical (Shenzhen) Co., Ltd. |
10/29/2025 |
|
P210006
S015 |
30-Day Notice | Thoraflex™ Hybrid | Vascutek, Ltd. | 10/29/2025 |
|
P220002
S010 |
30-Day Notice | TOPS™ System | Premia Spine, Ltd. | 10/29/2025 |
|
P240036
S002 |
30-Day Notice | OmniaSecure™ MRI SureScan™ Lead Model 3930M |
Medtronic, Inc. | 10/29/2025 |
|
P980023
S141 |
30-Day Notice | Pamira S 60 428768 Pamira S 65 428769 Pamira S 75 428770 Pamira SD 60/16 428771 Pamira SD 65/16 428772 Pamira SD 65/18 4 |
Biotronik, Inc. | 10/29/2025 |
|
P010031
S906 |
30-Day Notice | Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua |
Medtronic Cardiac Rhythm Disease Management |
10/28/2025 |
|
P150011
S033 |
30-Day Notice | PERCEVAL SUTURELESS HEART VALVE | Corcym S.R.L. | 10/28/2025 |
|
P150011
S034 |
30-Day Notice | Perceval Sutureless Heart Valve | Corcym S.R.L. | 10/28/2025 |
|
P150035
S033 |
30-Day Notice | Aveir VR Leadless Pacemaker; Aveir Leadless Pacemaker (Right Atrium); Aveir Leadless Pacemaker (Right Ventricle) |
Abbott, Medical | 10/28/2025 |
|
P180035
S031 |
Normal 180 Day Track No User Fee |
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses For Daily Wear |
Coopervision., Inc. | 10/28/2025 |
|
P190013
S001 |
Normal 180 Day Track | DBP-1400-ABE And DBP-2003- ABE | Aed Battery Exchange, LLC |
10/28/2025 |
|
P220012
S059 |
30-Day Notice | Aurora EV ICD (DVEA3E4) | Medtronic, Inc. | 10/28/2025 |
|
P810031
S080 |
30-Day Notice | Healon EndoCoat ™ PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD), Healon Duet ™ PRO II Dual Pack Sodium Hya |
Johnson & Johnson Surgical Vision, Inc. |
10/28/2025 |
|
P980016
S939 |
30-Day Notice | Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I |
Medtronic Cardiac Rhythm Disease Management |
10/28/2025 |
|
P040027
S099 |
Normal 180 Day Track | GORE® VIATORR® TIPS Endoprosthesis With Controlled Expansion |
W.L. Gore & Associates, Inc. |
10/27/2025 |
|
P150048
S092 |
Panel Track | TRIFORMIS RESILIA Tricuspid Valve | Edwards Lifesciences, LLC |
10/27/2025 |
|
P900056
S222 |
30-Day Notice | ROTAPRO™ Rotational Atherectomy System |
Boston Scientific Corp | 10/27/2025 |
|
N16895
S107 |
30-Day Notice | Bausch & Lomb SofLens® (polymacon) Contact Lenses |
Bausch & Lomb, Inc. | 10/24/2025 |
|
P010012
S593 |
Real-Time Process | ACUITY X4 Leads | Boston Scientific Corp | 10/24/2025 |
|
P090016
S068 |
30-Day Notice | Belotero Balance (+) Lidocaine Dermal Filler |
Merz North America, Inc. | 10/24/2025 |
|
P140028
S084 |
30-Day Notice | Innova™ Vascular Self-Expanding Stent System |
Boston Scientific Corporation |
10/24/2025 |
|
P180011
S067 |
30-Day Notice | Eluvia™ Drug-Eluting Vascular Stent System |
Boston Scientific Corp | 10/24/2025 |
|
P190016
S010 |
30-Day Notice | Tula® System | Tusker Medical, Inc. | 10/24/2025 |
|
P190019
S039 |
30-Day Notice | Ranger™ Paclitaxel-Coated PTA Balloon Catheter |
Boston Scientific Corporation |
10/24/2025 |
|
P910073
S182 |
Real-Time Process | ENDOTAK RELIANCE Leads | Boston Scientific | 10/24/2025 |
|
P960004
S109 |
Real-Time Process | FINELINE II Leads | Boston Scientific | 10/24/2025 |
|
P980040
S178 |
30-Day Notice | TECNIS Symfony Toric II OptiBlue Extended Range Of Vision IOL With TECNIS Simplicity Delivery System, Models DXW150-375; |
Johnson & Johnson Surgical Vision, Inc. |
10/24/2025 |
|
P230001
S011 |
30-Day Notice | ColoSense® | Geneoscopy, Inc. | 10/24/2025 |
|
P230035
S007 |
30-Day Notice | AGENT™ Paclitaxel-Coated Balloon Catheter |
Boston Scientific Corporation |
10/24/2025 |
