Calendar

Week of Dec 15, 2025

Dec 16, 2025device pma221d agoVistakon, Johnson & Johnson Vision Products, Inc. — ACUVUE CONTACT LENS (PMA supplement)JOHNSON & JOHNSON

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

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Dec 17, 2025device pma220d agoOn-X Life Technologies, Inc. — 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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Dec 17, 2025device pma220d agoIntegra LifeSciences Corporation — DuraSeal Exact Spine Sealant System (PMA supplement)INTEGRA LIFESCIENCES HOLDINGS CORP

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

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Dec 17, 2025device pma220d agoBoston Scientific Corp — Precision Spinal Cord Stimulator (SCS) Systems (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Dec 17, 2025device pma220d agoOrganox Limited — OrganOx metra® System (PMA supplement)

Supplement type: 30-Day Notice. Product code: QQK. Advisory committee: GU. Decision: OK30

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Dec 17, 2025device pma220d agoMentor Worldwide, LLC — MENTOR Saline-Filled and SPECTRUM Breast Implants (PMA supplement)Revalesio Corp

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

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Dec 17, 2025device pma220d agoMentor Worldwide, LLC — MENTOR MemoryShape Breast Implants (PMA supplement)

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

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Dec 17, 2025device pma220d agoInspire Medical Systems — INSPIRE II UPPER AIRWAY STIMULATOR (PMA supplement)Inspire Medical Systems, Inc.

Supplement type: 30-Day Notice. Product code: MNQ. Advisory committee: AN. Decision: OK30

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Dec 17, 2025device pma220d agoEdwards Lifesciences, LLC — Edwards INSPIRIS RESILIA Aortic Valve, Model 11500A, Sizes 19mm, 21mm, 23mm, 25mm, 27mm, and 29mm; Edwards KONECT RESILI (PMA supplement)Edwards Lifesciences Corp

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

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Dec 17, 2025device pma220d agoBiotronik, Inc. — Astron (PMA supplement)

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

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Dec 17, 2025device pma220d agoMentor Corp. — MENTOR MemoryGel Silicone Gel-Filled Breast Implants (PMA supplement)

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

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Dec 17, 2025device pma220d agoBoston Scientific Corp — Vercise Deep Brain Stimulation (DBS) Systems (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Dec 17, 2025device pma220d agoHologic, Inc. — NovaSure Model 10 RF Controller (PMA supplement)

Supplement type: 30-Day Notice. Product code: MNB. Advisory committee: OB. Decision: OK30

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Dec 17, 2025device pma220d agoMedtronic, Inc. — Activa Deep Brain Stimulation Therapy System (PMA supplement)Medtronic plc

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

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Dec 17, 2025device pma220d agoSyncardia Systems, LLC — SynCardia Total Artificial Heart (STAH) system (PMA supplement)

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

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Dec 17, 2025device pma220d agoKeri Medical SA — TOUCH® CMC 1 Prosthesis (PMA supplement)

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

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Dec 17, 2025device pma220d agoCorcym S.r.l. — Carbomedics Prosthetic Heart Valve; Carbomedics® Supra-annular Prosthetic Heart Valve; Carbo-Seal® Ascending Aortic Pros (PMA supplement)

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

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Dec 17, 2025device pma220d agoLivaNova USA, Inc. — VNS THERAPY SYSTEM (PMA supplement)

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

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Dec 17, 2025device pma220d agoCooperVision, Inc. — MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (PMA supplement)

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

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Dec 17, 2025device pma220d agoInstylla, Inc. — Embrace Hydrogel Embolic System (HES) (PMA supplement)

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

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Dec 17, 2025device pma220d agoABBOTT MEDICAL — HeartMate II Left Ventricular Assist System (PMA supplement)

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

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Dec 17, 2025device pma220d agoBoston Scientific Corp — ALTRUA 2 (Model S722); ESSENTIO (Model L121); PROPONENT (Model L221); ACCOLADE (Model L321) (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Dec 17, 2025device pma220d agoIntegra LifeSciences Corporation — DuraSeal Dural Sealant System (PMA supplement)INTEGRA LIFESCIENCES HOLDINGS CORP

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

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Dec 17, 2025device pma220d agoBiotronik, Inc. — Astron Pulsar; Pulsar-18; Pulsar-18 T3 (PMA supplement)

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

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Dec 17, 2025device pma220d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System (PMA supplement)

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

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Dec 17, 2025device pma220d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, Models 9755RSL20, 9755RSL23, 9755RSL26, and 9755RSL29 (PMA supplement)Edwards Lifesciences Corp

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

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Dec 17, 2025device pma220d agoBoston Scientific — ESSENTIO MRI (Model L131); PROPONENT MRI (Model L231); ACCOLADE MRI (Model L331) (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Dec 17, 2025device pma220d agoGuidant Corp. — VALITUDE (Model U125); VALITUDE X4 (Model U128); VISIONIST (Models U225, U226); VISIONIST X4 (Model U228) (PMA supplement)Guident Corp.

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

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Dec 17, 2025device pma220d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (sizes 20mm, 23mm, 26mm) 9750TFX; Edwards SAPIEN 3 Ultra RESILIA Transc (PMA supplement)Edwards Lifesciences Corp

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

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Dec 17, 2025device pma220d agoMotiva USA, LLC — Motiva SmoothSilk®Round; Round Ergonomix® Silicone Gel-Filled Breast Implants (PMA supplement)

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

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Dec 18, 2025device pma219d agoRenata Medical, Inc. — Minima Stent System (PMA supplement)

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

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Dec 18, 2025device pma219d agoBiotronik, Inc. — Acticor Sky HF-T 481986, Rivacor Sky HF-T 481991, Rivacor Rise HF-T 482017, Rivacor Aura HF-T 482013, Acticor Sky HF-T Q (PMA supplement)

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

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Dec 18, 2025device pma219d agoSpectranetics Corp. — ELCA Coronary Atherectomy Catheters (PMA supplement)

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

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Dec 18, 2025device pma219d agoBiotronik, Inc. — Acticor Sky DR-T 481987, Rivacor Sky DR-T 481982, Rivacor Rise DR-T 482018, Rivacor Aura DR-T 482014 (PMA supplement)

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

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Dec 18, 2025device pma219d agoCarl Zeiss Meditec, Inc. — VisuMax; VISUMAX 800 (PMA supplement)

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

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Dec 18, 2025device pma219d agoNeomend, Inc. — TRIDYNE Vascular Sealant (PMA supplement)

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

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Dec 18, 2025device pma219d agoBoston Scientific Corp — WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Cl (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Dec 18, 2025device pma219d agoChannel Medsystems, Inc. — Cerene® Cryotherapy Device (PMA supplement)

Supplement type: Special (Immediate Track). Product code: MNB. Advisory committee: OB. Decision: APPR

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Dec 18, 2025device pma219d agoZOLL Medical Corporation — X Series®; Propaq MD®; AED 3 BLS; Zenix Professional Defibrillators (PMA supplement)

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

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Dec 18, 2025device pma219d agoMedtronic Minimed, Inc. — MiniMed 670G System (PMA supplement)Medtronic USA Inc

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

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Dec 18, 2025device pma219d agoBiotronik, Inc. — Solia S 53 377177; Solia S 60 377179 (PMA supplement)

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

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Dec 18, 2025device pma219d 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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Dec 18, 2025device pma219d agoZOLL Medical Corporation — AED 3 (PMA supplement)

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

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Dec 18, 2025device pma219d agoIntrinsic Therapeutics — Barricaid® Annular Closure Device (PMA supplement)Insignis Therapeutics Inc

Supplement type: 30-Day Notice. Product code: QES. Advisory committee: OR. Decision: OK30

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Dec 18, 2025device pma219d agoBaxter Bio Science — Coseal Applicator Tips (PMA supplement)

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

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Dec 18, 2025device pma219d agoNeomend, Inc. — PROGEL Pleural Air Leak Sealant (PMA supplement)

Supplement type: 30-Day Notice. Product code: NBE. Advisory committee: AN. Decision: OK30

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Dec 18, 2025device pma219d agoMedtronic Neuromodulation — Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vec (PMA supplement)

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

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Dec 18, 2025device pma219d agoSymatese — Evolysse® FORM (PMA supplement)

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

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Dec 18, 2025device pma219d agoBoston Scientific Corp — WaveWriter Alpha Spinal Cord Stimulator (SCS) Mixed Systems, M8 Adaptor (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR

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Dec 18, 2025device pma219d agoBiotronik, Inc. — Acticor Sky VR-T 481989, Rivacor Sky VR-T 481984, Rivacor Rise VR-T 482020, Rivacor Aura VR-T 482015, Acticor Sky VR-T D (PMA supplement)

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

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Week of Dec 15, 2025