Calendar

Week of Oct 20, 2025

Oct 22, 2025device pma276d agoInspire Medical Systems — Inspire® Upper Airway Stimulation (PMA supplement)Inspire Medical Systems, Inc.

Supplement type: Normal 180 Day Track No User Fee. Product code: MNQ. Advisory committee: AN. Decision: APPR

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Oct 22, 2025device pma276d agoBoston Scientific — D010 INOGEN MINI ICD VR,D011 INOGEN MINI ICD VR,D012 INOGEN MINI ICD DR,D013 INOGEN MINI ICD DR,D020 DYNAGEN MINI I (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

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Oct 22, 2025device pma276d agoQIAGEN GmbH — therascreen® PIK3CA RGQ PCR Kit (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: OWD. Advisory committee: MG. Decision: APPR

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Oct 22, 2025device pma276d agoBoston Scientific Corp — G124 MOMENTUM CRT-D,G125 MOMENTUM CRT-D,G126 MOMENTUM CRT-D,G128 MOMENTUM,G138 MOMENTUM X4 CRT-D,G140 INOGEN CRT-D, (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30

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Oct 22, 2025device pma276d agoOn-X Life Technologies, Inc. — On-X Prosthetic Heart Valves; On-X Ascending Aortic Prothesis (PMA supplement)Lifeloc Technologies, Inc

Supplement type: 30-Day Notice. Product code: LWQ. Advisory committee: CV. Decision: OK30

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Oct 22, 2025device pma276d agoOn-X Life Technologies, Inc. — On-X Heart Valve; On-X Ascending Aortic Prosthesis (PMA supplement)Lifeloc Technologies, Inc

Supplement type: 30-Day Notice. Product code: LWQ. Advisory committee: CV. Decision: OK30

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Oct 23, 2025device pma275d agoABBOTT MEDICAL — Amplatzer Muscular VSD Occluder (PMA supplement)

Supplement type: 30-Day Notice. Product code: MLV. Advisory committee: CV. Decision: OK30

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Oct 23, 2025device pma275d agoBoston Scientific Corporation — ENROUTE® Transcarotid Stent System (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: NIM. Advisory committee: CV. Decision: OK30

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Oct 23, 2025device pma275d agoABBOTT MEDICAL — Amplatzer Duct Occluder; Amplatzer Duct Occluder II; Amplatzer Piccolo Occluder (PMA supplement)

Supplement type: 30-Day Notice. Product code: MAE. Advisory committee: CV. Decision: OK30

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Oct 23, 2025device pma275d agoMedtronic, Inc. — Mosaic Bioprosthesis, Models 305, 310 (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: DYE. Advisory committee: CV. Decision: OK30

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Oct 23, 2025device pma275d agoABBOTT MEDICAL — Amplatzer Amulet Left Atrial Appendage Occluder (PMA supplement)

Supplement type: 30-Day Notice. Product code: NGV. Advisory committee: CV. Decision: OK30

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Oct 23, 2025device pma275d agoMedtronic, Inc. — Freestyle Bioprosthesis, Models 995, 995CS, 995MS (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30

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Oct 23, 2025device pma275d agoMedtronic Vascular — Endurant II/IIs Stent Graft System (PMA supplement)

Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30

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Oct 23, 2025device pma275d agoMedtronic, Inc. — Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30

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Oct 23, 2025device pma275d agoMedtronic, Inc. — Avalus Bioprosthesis, Model 400 (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30

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Oct 23, 2025device pma275d agoMedtronic Neuromodulation — Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces-Quad, Spe (PMA supplement)

Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30

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Oct 23, 2025device pma275d agoBiotronik Nro, Inc. — Prospera SCS System; Resilience Percutaneous Lead; Embrace One; TrueLock (PMA supplement)

Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30

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Oct 23, 2025device pma275d agoMedtronic, Inc. — Melody Transcatheter Pulmonary Valve (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30

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Oct 23, 2025device pma275d agoABBOTT MEDICAL — Amplatzer Septal Occluder; Amplatzer Multi-Fenestrated Septal Occluder - Cribriform (PMA supplement)

Supplement type: 30-Day Notice. Product code: MLV. Advisory committee: CV. Decision: OK30

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Oct 23, 2025device pma275d agoABBOTT MEDICAL — Amplatzer PFO Occluder; Amplatzer Talisman PFO Occluder (PMA supplement)

Supplement type: 30-Day Notice. Product code: MLV. Advisory committee: CV. Decision: OK30

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Oct 23, 2025device pma275d agoMedtronic, Inc. — Hancock II Bioprosthesis, Models T505, T510 (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: DYE. Advisory committee: CV. Decision: OK30

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Oct 23, 2025device pma275d agoNovocure, GmbH — Optune Gio - Maxpoint Version 2.0 (PMA supplement)NovoCure Ltd

Supplement type: Normal 180 Day Track. Product code: NZK. Advisory committee: NE. Decision: APPR

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Oct 23, 2025device pma275d agoMedtronic, Inc. — Harmony Transcatheter Pulmonary Valve (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30

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Oct 24, 2025device pma274d agoBoston Scientific Corp — ACUITY X4 Leads (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: NIK. Advisory committee: CV. Decision: APPR

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Oct 24, 2025device pma274d agoBausch & Lomb, Inc. — Bausch & Lomb SofLens® (polymacon) Contact Lenses (PMA supplement)Bausch & Lomb Corp

Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30

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Oct 24, 2025device pma274d agoJohnson & Johnson Surgical Vision, Inc. — TECNIS Symfony Toric II OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System, Models DXW150-375; (PMA supplement)JOHNSON & JOHNSON

Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30

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Oct 24, 2025device pma274d agoGeneoscopy, Inc. — ColoSense® (PMA supplement)

Supplement type: 30-Day Notice. Product code: SBB. Advisory committee: PA. Decision: OK30

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Oct 24, 2025device pma274d agoBiotronik, Inc. — Edora 8 HF-T QP; Edora 8 HF-T; Evity 8 HF-T QP; Evity 8 HF-T; Enitra 8 HF-T QP; Enitra 8 HF-T; Enticos 8 HF-T QP; Entico (PMA supplement)

Supplement type: 135 Review Track For 30-Day Notice. Product code: NKE. Advisory committee: CV. Decision: APPR

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Oct 24, 2025device pma274d agoBoston Scientific — ENDOTAK RELIANCE Leads (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: LWS. Advisory committee: CV. Decision: APPR

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Oct 24, 2025device pma274d agoBiotronik, Inc. — Acticor 7 VR-T; Rivacor 7 VR-T; Rivacor 5 VR-T; Rivacor 3 VR-T; Acticor 7 VR-T DX; Rivacor 7 VR-T DX; Rivacor 5 VR-T DX; (PMA supplement)

Supplement type: 135 Review Track For 30-Day Notice. Product code: MRM. Advisory committee: CV. Decision: APPR

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Oct 24, 2025device pma274d agoBoston Scientific — FINELINE II Leads (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: NVN. Advisory committee: CV. Decision: APPR

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Oct 24, 2025device pma274d agoBoston Scientific Corp — Eluvia Drug-Eluting Vascular Stent System (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: NIU. Advisory committee: CV. Decision: OK30

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Oct 24, 2025device pma274d agoBoston Scientific Corporation — AGENT Paclitaxel-Coated Balloon Catheter (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: OOB. Advisory committee: CV. Decision: OK30

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Oct 24, 2025device pma274d agoBoston Scientific Corporation — Innova Vascular Self-Expanding Stent System (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30

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Oct 24, 2025device pma274d agoBiotronik, Inc. — Edora 8 DR-T; Evity 8 DR-T; Enitra 8 DR-T; Enticos 8 DR-T; Evity 6 DR-T; Enitra 6 DR-T; Edora 8 DR; Enitra 6 DR; Edora 8 (PMA supplement)

Supplement type: 135 Review Track For 30-Day Notice. Product code: DXY. Advisory committee: CV. Decision: APPR

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Oct 24, 2025device pma274d agoMerz North America, Inc. — Belotero Balance (+) Lidocaine Dermal Filler (PMA supplement)Sustained Therapeutics Inc

Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30

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Oct 24, 2025device pma274d agoBoston Scientific Corporation — Ranger Paclitaxel-Coated PTA Balloon Catheter (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: ONU. Advisory committee: CV. Decision: OK30

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Oct 24, 2025device pma274d agoTusker Medical, Inc. — Tula® System (PMA supplement)

Supplement type: 30-Day Notice. Product code: QJA. Advisory committee: EN. Decision: OK30

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Week of Oct 27, 2025

Oct 27, 2025device pma271d agoW. L. Gore & Associates, Inc. — GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: MIR. Advisory committee: CV. Decision: APPR

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Oct 27, 2025device pma

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