| PMA Number | Suppl. Type | Device Name | Applicant | Decision Date |
|---|---|---|---|---|
|
P130008
S133 |
30-Day Notice | QMR Battery Separator Supplier | Inspire Medical Systems | 01/30/2026 |
|
P140010
S091 |
135 Review Track For 30-Day Notice |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter And IN.PACT 018 Paclitax |
Medtronic, Inc. | 01/30/2026 |
|
P180011
S060 |
Normal 180 Day Track No User Fee |
Eluvia Drug-Eluting Vascular Stent System |
Boston Scientific Corp | 01/30/2026 |
| P250009 | Original | SQUID Liquid Embolic Agent (LEA) | Balt USA, LLC | 01/30/2026 |
|
P830055
S359 |
30-Day Notice | LCS® Total Knee System | Depuy, Inc. | 01/30/2026 |
|
P010030
S199 |
30-Day Notice | LifeVest® Wearable Defibrillator | Zoll Manufacturing Corporation |
01/29/2026 |
|
P040024
S143 |
Normal 180 Day Track | Restylane®-L 1 Ml; Restylane® Lyft™ With Lidocaine 1 Ml; Restylane® Eyelight™ 0.5 Ml |
Q-Med AB | 01/29/2026 |
|
P120024
S014 |
Normal 180 Day Track No User Fee |
Activl Artificial Disc | Highridge Medical, LLC | 01/29/2026 |
|
P210006
S016 |
Special (Immediate Track) |
Thoraflex™ Hybrid | Vascutek, Ltd. | 01/29/2026 |
|
P230032
S003 |
Normal 180 Day Track No User Fee |
AvertD™ And AvertD™ Buccal Sample Collection Kit |
AutoGenomics, Inc. | 01/29/2026 |
|
P130018
S005 |
Special (Immediate Track) |
ProACT™ Adjustable Continence Therapy For Men |
Uromedica, Inc. | 01/28/2026 |
|
P150038
S043 |
30-Day Notice | Exablate Model 4000 System | Insightec | 01/28/2026 |
|
P200015
S068 |
Normal 180 Day Track | Edwards SAPIEN 3 Transcatheter Pulmonic Valve Delivery System |
Edwards Lifesciences, LLC |
01/28/2026 |
|
P210007
S010 |
30-Day Notice | Vivistim® System | Micro Transponder, Inc. | 01/28/2026 |
|
P240009
S007 |
135 Review Track For 30-Day Notice |
Neuroguard IEP® 3-in-1 Carotid Stent And Post- Dilatation Balloon System With Integrated Embolic Protection |
Contego Medical, Inc. | 01/28/2026 |
|
P240015
S001 |
30-Day Notice | Womed Leaf | Womed Sas | 01/28/2026 |
|
P240035
S003 |
Normal 180 Day Track No User Fee |
ETHIZIA™ Hemostatic Patch | Ethicon, Inc. | 01/28/2026 |
|
P980018
S026 |
Special (Immediate Track) |
HercepTest™ | Agilent Technologies Singapore (International) Pte , Ltd. |
01/28/2026 |
|
P980035
S833 |
30-Day Notice | Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Attesta DR MRl IPG; Attesta DR MRl IPG; |
Medtronic, Inc. | 01/28/2026 |
|
P990004
S077 |
30-Day Notice | SURGIFOAM Absorbable Gelatin Sponge, USP |
Ferrosan Meidcal Devices A/S |
01/28/2026 |
|
P100021
S133 |
30-Day Notice | Endurant Stent Graft System; Endurant II/IIs Stent Graft System; Endurant II AUI Stent Graft System |
Medtronic Vascular | 01/27/2026 |
|
P950020
S148 |
30-Day Notice | WOLVERINE™ Coronary Cutting Balloon™ |
Boston Scientific Corp | 01/27/2026 |
|
P180047
S039 |
Normal 180 Day Track | LIAISON QuantiFERON TB Gold Plus II; LIAISON Control QuantiFERON TB Gold Plus II |
DiaSorin, Inc. | 01/26/2026 |
|
P000025
S137 |
Normal 180 Day Track No User Fee |
MED-EL Cochlear Implant | Med-El Corp. | 01/23/2026 |
|
P010015
S576 |
30-Day Notice | Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRTP; Serena Quadripolar CRT-P; Solar |
Medtronic, Inc. | 01/23/2026 |
|
P010015
S577 |
30-Day Notice | Percepta Bipolar CRT-P; Perceota Quadrioolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P |
Medtronic, Inc. | 01/23/2026 |
|
P010031
S912 |
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 |
01/23/2026 |
|
P010033
S052 |
30-Day Notice | QuantiFERON®-TB Gold Test And QuantiFERON®-TB Gold Plus Test |
Qiagen | 01/23/2026 |
|
P060001
S054 |
30-Day Notice | Protégé RX Carotid Stent System | Medtronic Vascular, Inc. | 01/23/2026 |
|
P160007
S058 |
Real-Time Process | MiniMed Go App; Simplera Sensor | Medtronic Minimed | 01/23/2026 |
|
P220012
S064 |
30-Day Notice | Aurora EV-ICD System | Medtronic, Inc. | 01/23/2026 |
|
P960058
S170 |
135 Review Track For 30-Day Notice |
HiResolution Bionic Ear System | Advanced Bionics | 01/23/2026 |
|
P980016
S945 |
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 ICD; Eve |
Medtronic Cardiac Rhythm Disease Management |
01/23/2026 |
|
P980035
S828 |
30-Day Notice | Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Advisa DR IPG; Advisa DR MRI IPG; Advis |
Medtronic, Inc. | 01/23/2026 |
|
P980035
S830 |
30-Day Notice | Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S SR MRI IPG |
Medtronic, Inc. | 01/23/2026 |
|
P030017
S391 |
30-Day Notice | Precision Spinal Cord Stimulator (SCS) Systems |
Boston Scientific Corp | 01/22/2026 |
|
P150031
S091 |
30-Day Notice | Vercise Deep Brain Stimulation (DBS) Systems |
Boston Scientific Corp | 01/22/2026 |
|
P220021
S007 |
135 Review Track For 30-Day Notice |
DETOUR System | Endologix, LLC | 01/22/2026 |
|
P240035
S001 |
30-Day Notice | ETHIZIA™ Hemostatic Patch | Ethicon, Inc. | 01/22/2026 |
|
P030017
S377 |
Normal 180 Day Track | Precision Spinal Cord Stimulator (SCS) Systems |
Boston Scientific Corp | 01/21/2026 |
|
P190016
S011 |
30-Day Notice | Tula Tube Delivery System (TDS) | Tusker Medical, Inc. | 01/21/2026 |
|
P060011
S044 |
30-Day Notice | Rayner C-flex 570C, C-flex Aspheric 970C, 600C Aspheric Intraocular Lenses, RayOne Aspheric RAO600C, RayOne Spheric RAO1 |
Rayner Intraocular Lenses , Ltd. |
01/20/2026 |
|
P080025
S319 |
135 Review Track For 30-Day Notice |
InterStim TM Therapy System, Verify ™ Evaluation System |
Medtronic Neuromodulation |
01/20/2026 |
|
P860004
S443 |
135 Review Track For 30-Day Notice |
SynchroMed ™ Infusion System, Ascenda ® Intrathecal Catheters |
Medtronic, Inc. | 01/20/2026 |
|
P970004
S424 |
135 Review Track For 30-Day Notice |
InterStim TM Therapy System, Verify ™ Evaluation System |
Medtronic Neuromodulation |
01/20/2026 |
|
P010014
S113 |
Special (Immediate Track) |
Oxford Partial Knee System | Biomet Manufacturing Corp |
01/16/2026 |
|
P010031
S913 |
30-Day Notice | Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D |
Medtronic Cardiac Rhythm Disease Management |
01/16/2026 |
|
P060037
S096 |
Special (Immediate Track) |
NexGen® LPS-Flex / LPS Mobile Bearing Knee System |
Zimmer, Inc. | 01/16/2026 |
|
P100049
S040 |
30-Day Notice | LINX™ Reflux Management System | Torax Medical | 01/16/2026 |
|
P100049
S041 |
30-Day Notice | LINX Reflux Management System | Torax Medical | 01/16/2026 |
|
P200046
S047 |
30-Day Notice | Harmony™ Transcatheter Pulmonic Valve System |
Medtronic, Inc. | 01/16/2026 |
|
P220014
S010 |
Normal 180 Day Track No User Fee |
CraniSeal Dural Sealant | Pramand, LLC | 01/16/2026 |
|
P240039
S001 |
Normal 180 Day Track No User Fee |
SetPoint System | SetPoint Medical | 01/16/2026 |
|
P830055
S356 |
Special (Immediate Track) |
LCS® Total Knee System | Depuy, Inc. | 01/16/2026 |
|
P980016
S946 |
30-Day Notice | Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD |
Medtronic Cardiac Rhythm Disease Management |
01/16/2026 |
|
P200010
S026 |
Panel Track | Guardant360 CDx | Guardant Health, Inc. | 01/15/2026 |
|
N12159
S128 |
30-Day Notice | SURGICEL® Absorbable Hemostats | Ethicon, Inc. | 01/15/2026 |
|
P040042
S058 |
30-Day Notice | Safire™ TX Bi-directional And Therapy™ Dual-8™ |
Irvine Biomedical,Inc.(Ibi) |
01/15/2026 |
|
P070001
S030 |
30-Day Notice | Prodisc® C | Centinel Spine, LLC | 01/15/2026 |
|
P110016
S092 |
30-Day Notice | FlexAbility™ And FlexAbility™ Sensor Enabled™ |
Abbott Medical | 01/15/2026 |
|
P130010
S005 |
30-Day Notice | VEGA Steroid-Eluting Endocardial Leads (VEGA™ R45, VEGA™ R52, And VEGA™ R58) |
Microport Crm, USA, Inc. | 01/15/2026 |
|
P130026
S098 |
30-Day Notice | TactiCath™ Sensor Enabled™ | St Jude Medical | 01/15/2026 |
|
P220013
S026 |
30-Day Notice | TactiFlex™ Sensor Enabled™ | Abbott Medical | 01/15/2026 |
|
P230023
S010 |
Normal 180 Day Track No User Fee |
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis |
W.L. Gore & Associates, Inc. |
01/15/2026 |
|
P880047
S069 |
30-Day Notice | GYNECARE INTERCEED™ Absorbable Adhesion Barrier |
Ethicon, Inc. | 01/15/2026 |
|
P960016
S093 |
30-Day Notice | Livewire™ TC XLS™ | St Jude Medical | 01/15/2026 |
|
P080025
S338 |
30-Day Notice | InterStim Therapy System, Verify Evaluation System |
Medtronic Neuromodulation |
01/14/2026 |
|
P130005
S048 |
Special (Immediate Track) |
Diamondback 360™ Coronary Orbital Atherectomy System; Diamondback 360 Precision™ Coronary Orbital Atherectomy System |
Cardiovascular Systems, Inc. |
01/14/2026 |
|
P170002
S051 |
Special (Immediate Track) |
RHA® Redensity Dermal Filler | Teoxane S.A. | 01/14/2026 |
|
P180046
S104 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
01/14/2026 |
|
P190006
S104 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
01/14/2026 |
|
P220024
S005 |
Normal 180 Day Track No User Fee |
LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device |
Advanced Medical Solutions Limited |
01/14/2026 |
|
P240011
S005 |
30-Day Notice | Altaviva | Medtronic Neuromodulation |
01/14/2026 |
|
P240012
S004 |
30-Day Notice | AeroPace® System | Lungpacer Medical USA, Inc. |
01/14/2026 |
|
P970004
S443 |
30-Day Notice | InterStim™ Therapy System, Verify™ Evaluation System |
Medtronic Neuromodulation |
01/14/2026 |
|
P010032
S237 |
Normal 180 Day Track | Eterna SCS And Proclaim SCS Systems | Abbott Medical | 01/13/2026 |
|
P040047
S080 |
30-Day Notice | COAPTITE | Merz North America, Inc. | 01/13/2026 |
|
P050037
S149 |
30-Day Notice | RADIESSE® Injectable Implant | Merz North America, Inc. | 01/13/2026 |
|
P050052
S174 |
30-Day Notice | RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, Jawline Indication |
Merz North America, Inc. | 01/13/2026 |
|
P150004
S085 |
Normal 180 Day Track | Proclaim Dorsal Root Ganglion (DRG) Neurostimulator System |
Abbott Medical | 01/13/2026 |
|
P180046
S103 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
01/13/2026 |
|
P190006
S103 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
01/13/2026 |
|
P230022
S006 |
30-Day Notice | Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati |
Element Science, Inc. | 01/13/2026 |
|
P230030
S017 |
30-Day Notice | FARAPULSE™ Pulsed Field Ablation System (FARAPULSE) |
Farapulse, Inc. | 01/13/2026 |
|
P080010
S030 |
30-Day Notice | TECNIS Multi-focal 3-pc, ZMA00 | Johnson & Johnson Surgical Vision, Inc. |
01/12/2026 |
|
P110043
S015 |
Special (Immediate Track) |
Omnilink Elite Vascular Balloon-Expandable Stent System |
Abbott Vascular-Cardiac Therapies |
01/12/2026 |
|
P230030
S012 |
Panel Track | FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation C |
Farapulse, Inc. | 01/12/2026 |
|
P980040
S181 |
30-Day Notice | SENSAR 1-piece IOL, AAB00; SENSAR Soft Acrylic Posterior Chamber IOL, Models AR40e, AR40E, And AR40M; TECNIS 1-Piece I |
Johnson & Johnson Surgical Vision, Inc. |
01/12/2026 |
|
P990080
S065 |
30-Day Notice | TECNIS Foldable Acrylic IOL With OptiEdge, 13.0 Mm, ZA9003 |
Johnson & Johnson Surgical Vision, Inc. |
01/12/2026 |
|
P100045
S082 |
135 Review Track For 30-Day Notice |
CardioMEMS™ HF System | Abbott Medical | 01/09/2026 |
|
P150012
S177 |
30-Day Notice | INGEVITY™ Family Bradycardia Leads | Boston Scientific | 01/09/2026 |
|
P230040
S025 |
30-Day Notice | Cordella Pulmonary Artery Sensor System (CorPASS) |
Endotronix, Inc. | 01/09/2026 |
|
P240044
S004 |
30-Day Notice | Globe® Catheter; Globe® Pulsed Field System |
Kardium, Inc. | 01/09/2026 |
|
N970003
S301 |
135 Review Track For 30-Day Notice |
Accolade Pacemakers: ACCOLADE Models: L300, L301, L321; ALTRUA 2 Models: S701, S702, S722; ESSENTIO Models: L100, L101, |
Boston Scientific Corp | 01/08/2026 |
|
P010012
S592 |
135 Review Track For 30-Day Notice |
NG3 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds): DYNAGEN Models: G150, G151, G154, G156, G158; INOGEN Mode |
Boston Scientific Corp | 01/08/2026 |
|
P020036
S059 |
30-Day Notice | S.M.A.R.T.® And S.M.A.R.T.® CONTROL® Vascular Stent System; S.M.A.R.T. RADIANZ™ Vascular Stent System |
Cordis US Corporation | 01/08/2026 |
|
P030005
S247 |
135 Review Track For 30-Day Notice |
Accolade CRT – Pacemakers (CRT-Ps): VALITUDE CRT-P U125; VALITUDE X4 CRT-P Model U128; VISIONIST CRT-P Models U225, U226 |
Guidant Corp. | 01/08/2026 |
|
P030036
S155 |
30-Day Notice | SelectSecure Lead 3830 | Medtronic Cardiac Rhythm Disease Management |
01/08/2026 |
|
P030047
S053 |
30-Day Notice | PRECISE® PRO RX Nitinol Stent System; PRECISE® PRO Transcarotid Stent System |
Cordis US Corporation | 01/08/2026 |
|
P070026
S118 |
135 Review Track For 30-Day Notice |
Ceramax® Ceramic Total Hip System | DePuy Orthopaedics, Inc. | 01/08/2026 |
|
P100013
S033 |
30-Day Notice | EXOSEAL® Vascular Closure Device | Cordis US Corporation | 01/08/2026 |
|
P110016
S091 |
30-Day Notice | FlexAbility™ Ablation Catheter (Flex) And FlexAbility™ Ablation Catheter, Sensor Enabled™ (Flex SE) |
Abbott Medical | 01/08/2026 |
|
P110042
S204 |
135 Review Track For 30-Day Notice |
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD): EMBLEM S-ICD Model A209 And EMBLEM MRI S-ICD Model A219 |
Boston Scientific Corporation |
01/08/2026 |
|
P120002
S034 |
30-Day Notice | S.M.A.R.T.® And S.M.A.R.T.® CONTROL® Vascular Stent Systems; S.M.A.R.T. RADIANZ™ Vascular Stent System |
Cordis US Corporation | 01/08/2026 |
|
P130026
S097 |
30-Day Notice | TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) |
St Jude Medical | 01/08/2026 |
|
P140026
S033 |
30-Day Notice | ENROUTE Transcarotid Stent System | Boston Scientific Corporation |
01/08/2026 |
|
P150012
S169 |
135 Review Track For 30-Day Notice |
Accolade MRI Pacemakers- ACCOLADE MRI Models: L310, L311, L331; ESSENTIO MRI Models: L110, L111, L131; PROPONENT Models: |
Boston Scientific | 01/08/2026 |
|
P160008
S032 |
30-Day Notice | HeartSine’s Samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P And SAM 450P) And Accessories |
Heartsine Technologies, Ltd. |
01/08/2026 |
|
P220013
S025 |
30-Day Notice | TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex SE) |
Abbott Medical | 01/08/2026 |
|
P220030
S009 |
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 | 01/08/2026 |
|
P230012
S009 |
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 | 01/08/2026 |
|
P960040
S505 |
135 Review Track For 30-Day Notice |
NG3 Implantable Cardioverter Defibrillators (ICDs): DYNAGEN Models: D020, D021, D022, D023, D150, D151, D152, D153; INOG |
Boston Scientific | 01/08/2026 |
|
P080011
S194 |
30-Day Notice | Comfilcon A Soft (Hydrophilic) Contact Lenses For Daily Wear |
CooperVision, Inc. | 01/07/2026 |
|
P180003
S013 |
30-Day Notice | BioMimics 3D® Vascular Stent System | Veryan Medical, Ltd. | 01/07/2026 |
|
P180046
S102 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
01/07/2026 |
|
P190006
S102 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
01/07/2026 |
|
P220025
S008 |
30-Day Notice | LimFlow System | LimFlow, Inc. | 01/07/2026 |
|
P230042
S005 |
30-Day Notice | Optune Lua® | Novocure, GmbH | 01/07/2026 |
|
P190002
S036 |
Normal 180 Day Track No User Fee |
Saluda Medical Evoke SCS System | Saluda Medical Pty., Ltd. |
01/06/2026 |
|
P100013
S032 |
30-Day Notice | EXOSEAL® Vascular Closure Device | Cordis US Corporation | 01/06/2026 |
|
P200019
S013 |
30-Day Notice | VENTANA Anti-msh6 (SP93) Antibody | Ventana Medical Systems | 01/06/2026 |
|
P210001
S015 |
30-Day Notice | VENTANA Anti-msh6 (SP93) Antibody | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) |
01/06/2026 |
|
P230003
S010 |
30-Day Notice | Alinity M HR HPV | Abbott Molecular, Inc. | 01/06/2026 |
|
P230043
S003 |
30-Day Notice | Stool DNA (sDNA) Test, Cologuard Plus™ |
Exact Sciences Corporation |
01/06/2026 |
|
P240044
S003 |
30-Day Notice | Globe® Pulsed Field System | Kardium, Inc. | 01/06/2026 |
|
P000037
S068 |
30-Day Notice | On-X Prosthetic Heart Valves And Ascending Aortic Prothesis |
On-X Life Technologies, Inc. |
01/05/2026 |
|
P010031
S911 |
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 |
01/05/2026 |
|
P140008
S028 |
Normal 180 Day Track No User Fee |
ORBERA INTRAGASTRIC BALLOON | Boston Scientific Corporation |
01/05/2026 |
|
P220012
S063 |
30-Day Notice | Aurora EV ICD DVEA3E4 | Medtronic, Inc. | 01/05/2026 |
| P240014 | Original | MAGiC Ablation Catheter | Stereotaxis, Inc. | 01/05/2026 |
|
P980016
S944 |
30-Day Notice | Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4 Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4 Crome MRI ICD DDP |
Medtronic Cardiac Rhythm Disease Management |
01/05/2026 |
|
P030053
S086 |
30-Day Notice | MENTOR™ MemoryGel™ Silicone Gel-Filled Breast Implants |
Mentor Corp. | 01/02/2026 |
|
P060028
S059 |
30-Day Notice | MENTOR™ MemoryShape™ Breast Implants |
Mentor Worldwide, LLC | 01/02/2026 |
|
P170023
S023 |
30-Day Notice | Bulkamid Urethral Bulking System | Boston Scientific Corporation |
01/02/2026 |
|
P240006
S013 |
30-Day Notice | VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; Ngen™ Pump |
Biosense Webster, Inc. | 01/02/2026 |
|
BP953200
S136 |
30-Day Notice | Apligraf | Organogenesis, Inc. | 12/31/2025 |
|
P000057
S013 |
135 Review Track For 30-Day Notice |
Ascension MCP | Smith & Nephew, Inc. | 12/31/2025 |
|
P100020
S064 |
30-Day Notice | Cobas® HPV | Roche Molecular Systems, Inc. |
12/31/2025 |
|
P110020
S043 |
30-Day Notice | Cobsa® BRAF V600 Mutation Test | Roche Molecular Systems, Inc. |
12/31/2025 |
|
P120019
S042 |
30-Day Notice | Cobas® EGFR Mutation Test, V2.0 | Roche | 12/31/2025 |
|
P140023
S031 |
30-Day Notice | Cobas® KRAS Mutation Test | Roche Molecular Systems, Inc. |
12/31/2025 |
|
P190028
S022 |
30-Day Notice | Cobas® HPV | Roche Molecular Systems, Inc. |
12/31/2025 |
|
P200014
S010 |
30-Day Notice | Cobas® EZH2 Mutation Test | Roche Molecular System, Inc. |
12/31/2025 |
| P250010 | Original | Proliv™Rx System | Neurolief , Ltd. | 12/31/2025 |
|
P160022
S049 |
30-Day Notice | OneStep CPR Complete Electrode | ZOLL Medical Corporation | 12/30/2025 |
|
P200010
S028 |
30-Day Notice | Guardant360 CDx | Guardant Health, Inc. | 12/29/2025 |
|
P010032
S246 |
30-Day Notice | Proclaim™ Spinal Cord Stimulation (SCS) System |
Abbott Medical | 12/23/2025 |
|
P040024
S146 |
Normal 180 Day Track No User Fee |
Restylane® Lyft With Lidocaine | Q-Med AB | 12/23/2025 |
|
P060011
S043 |
30-Day Notice | C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) |
Rayner Intraocular Lenses , Ltd. |
12/23/2025 |
|
P080025
S337 |
30-Day Notice | InterStim™ Therapy System, Verify™ Evaluation System |
Medtronic Neuromodulation |
12/23/2025 |
|
P130026
S096 |
Real-Time Process | TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ |
St Jude Medical | 12/23/2025 |
|
P140009
S127 |
30-Day Notice | Infinity™ Deep Brain Stimulation (DBS) System |
Abbott Medical | 12/23/2025 |
|
P150004
S092 |
30-Day Notice | Proclaim Dorsal Root Ganglion (DRG) System |
Abbott Medical | 12/23/2025 |
|
P170007
S015 |
30-Day Notice | DUROLANE | Bioventus, LLC | 12/23/2025 |
|
P170016
S001 |
30-Day Notice | SYNOJOYNT™ | Arthrex, Inc. | 12/23/2025 |
|
P180035
S033 |
30-Day Notice | MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses For Daily Wear |
CooperVision, Inc. | 12/23/2025 |
|
P200049
S014 |
Real-Time Process | Amplatzer™ Amulet™ Left Atrial Appendage Occluder |
Abbott Medical | 12/23/2025 |
|
P220021
S008 |
30-Day Notice | DETOUR System | Endologix, LLC | 12/23/2025 |
|
P240006
S012 |
Real-Time Process | TRUPULSE™ Generator | Biosense Webster, Inc. | 12/23/2025 |
|
P830063
S031 |
30-Day Notice | Gambro Prismaflex TPE 2000 Set | Vantive US Healthcare, LLC |
12/23/2025 |
|
BP130076
S086 |
30-Day Notice | INTERCEPT(R) Blood System For Plasma | Cerus Corporation | 12/23/2025 |
|
BP140143
1152 |
30-Day Notice | INTERCEPT(R) Blood Systerm For Platelets |
Cerus Corporation | 12/23/2025 |
|
P970004
S442 |
30-Day Notice | InterStim™ Therapy System, Verify™ Evaluation System |
Medtronic Neuromodulation |
12/23/2025 |
|
P990071
S068 |
Real-Time Process | Ngen™ Pump | Biosense Webster, Inc. | 12/23/2025 |
| P250019 | Original | SAPIEN M3 Transcatheter Mitral Valve Replacement System |
Edwards Lifesciences, LLC |
12/22/2025 |
|
P080025
S336 |
30-Day Notice | InterStim Therapy System; Verify Evaluation System |
Medtronic Neuromodulation |
12/22/2025 |
|
P120003
S009 |
Normal 180 Day Track | Icast Covered Stent System | Atrium Medical Corp. | 12/22/2025 |
|
P150011
S035 |
30-Day Notice | Perceval Sutureless Heart Valve | Corcym S.R.L. | 12/22/2025 |
|
P160008
S031 |
30-Day Notice | Samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P And SAM 450P) And Accessories |
Heartsine Technologies, Ltd. |
12/22/2025 |
|
P160042
S029 |
30-Day Notice | Revanesse Versa; Revanesse Versa+ (with Lidocaine); Revanesse Lips+ (with Lidocaine) |
Prollenium Medical Technologies, Inc. |
12/22/2025 |
|
P230009
S011 |
30-Day Notice | Shield | Guardant Health, Inc. | 12/22/2025 |
|
P840001
S616 |
30-Day Notice | Master Restore; Itrel; Synergy; Intellis; Vanta And Inceptiv Spinal Cord Stimulation Systems And Pisces; Specify; And Ve |
Medtronic Neuromodulation |
12/22/2025 |
|
P860004
S455 |
30-Day Notice | SynchroMed Infusion System; Ascenda Intrathecal Catheters |
Medtronic, Inc. | 12/22/2025 |
|
P910071
S019 |
30-Day Notice | ADATO SIL-OL 5000 Silicone Oils | Bausch & Lomb | 12/22/2025 |
|
P960009
S527 |
30-Day Notice | Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense |
Medtronic, Inc. | 12/22/2025 |
|
P970004
S441 |
30-Day Notice | InterStim Therapy System; Verify Evaluation System |
Medtronic Neuromodulation |
12/22/2025 |
| P250022 | Original | Volt™ PFA System | Abbott Medical | 12/19/2025 |
| P250017 | Original | GORE® VIABAHN® FORTEGRA Venous Stent |
W.L. Gore & Associates, Inc. |
12/19/2025 |
|
N970003
S304 |
Real-Time Process | ALTRUA™ 2 (Models S701, S702, S722) ESSENTIO™ (Models L100, L101, L121) PROPONENT™ (Models L200, L201, L221) ACCOLADE™ ( |
Boston Scientific Corp | 12/19/2025 |
|
P010015
S574 |
Normal 180 Day Track | Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol |
Medtronic, Inc. | 12/19/2025 |
|
P010031
S905 |
Normal 180 Day Track | Cobalt MRI CRT-D DTPB2D1, DTPB2D4 NIK Cobalt XT MRI CRT-D DTPA2D1, DTPA2D4 NIK Crome MRI CRT-D DTPC2D1, DTPC2D4 |
Medtronic Cardiac Rhythm Disease Management |
12/19/2025 |
|
P030005
S250 |
Real-Time Process | VALITUDE™ (Model U125) VALITUDE™ X4 (Model U128) VISIONIST™ (Models U225, U226) VISIONIST™ X4 (Model U228) Firmware Vers |
Guidant Corp. | 12/19/2025 |
|
P050006
S116 |
30-Day Notice | GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder |
W.L. Gore & Associates, Inc. |
12/19/2025 |
|
P060019
S058 |
30-Day Notice | Cool Point™ Tubing Set | Irvine Biomedical, Inc. | 12/19/2025 |
|
P140003
S136 |
30-Day Notice | Impella CP With SmartAssist; Impella 5.5 With SmartAssist |
Abiomed, Inc. | 12/19/2025 |
|
P150012
S173 |
Real-Time Process | ESSENTIO™ MRI (Models L110, L111, L131) PROPONENT™ MRI (Models L210, L211, L231) ACCOLADE™ MRI (Models L310, L311, L331) |
Boston Scientific | 12/19/2025 |
|
P160035
S055 |
30-Day Notice | EXCOR Pediatric Ventricular Assist Device |
Berlin Heart, Inc. | 12/19/2025 |
|
P160043
S089 |
30-Day Notice | Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX And OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S |
Medtronic Vascular | 12/19/2025 |
|
P170011
S062 |
30-Day Notice | Impella CP With SmartAssist; Impella 5.5 With SmartAssist |
Abiomed, Inc. | 12/19/2025 |
|
P180046
S101 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
12/19/2025 |
|
P180047
S041 |
30-Day Notice | LIAISON® QuantiFERON-TB Gold Plus And LIAISON® Control QuantiFERON-TB Gold Plus |
DiaSorin, Inc. | 12/19/2025 |
|
P190006
S101 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
12/19/2025 |
|
P200007
S002 |
30-Day Notice | HeartSync Multifunction Disposable Single-Use Defibrillator Pads |
Graphic Controls D.B.A. Vermed |
12/19/2025 |
|
P220034
S008 |
30-Day Notice | LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus |
DiaSorin, Inc. | 12/19/2025 |
|
P230040
S015 |
Normal 180 Day Track | CorPASS System | Endotronix, Inc. | 12/19/2025 |
|
P230044
S002 |
Real-Time Process | Alfapump System | Sequana Medical NV | 12/19/2025 |
|
P240011
S004 |
Normal 180 Day Track No User Fee |
Medtronic Altaviva System | Medtronic Neuromodulation |
12/19/2025 |
|
P240022
S004 |
Real-Time Process | Evolysse Injectable Hyaluronic Acid | Symatese | 12/19/2025 |
|
P860004
S453 |
Normal 180 Day Track | SynchroMed™ Infusion Systems | Medtronic, Inc. | 12/19/2025 |
|
P970051
S240 |
30-Day Notice | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | Cochlear Americas | 12/19/2025 |
