Calendar

Week of Dec 15, 2025

Dec 17, 2025device 510k256d agoUnibeauty (Hubei) Technology Co., Ltd. — Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons (510k cleared)

Product code: HEB. Advisory committee: Obstetrics/Gynecology. Type: Special

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Dec 17, 2025device 510k256d agoRoche Diagnostics — Elecsys Anti-SARS-CoV-2 (510k cleared)

Product code: QVP. Advisory committee: Microbiology. Type: Special

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Dec 17, 2025device 510k256d agoBonebridge AG — BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System (510k cleared)

Product code: HRS. Advisory committee: Orthopedic. Type: Traditional

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Dec 17, 2025device 510k256d agoUltrasight , Ltd. — UltraSight Guidance (510k cleared)

Product code: QJU. Advisory committee: Radiology. Type: Traditional

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Dec 17, 2025device 510k256d agoHighridge Medical, LLC — Vital Spinal Fixation System (510k cleared)

Product code: NKB. Advisory committee: Orthopedic. Type: Traditional

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Dec 17, 2025device 510k256d agoDuopross Meditech Corporate — DuoprossTM Smart Cap (Type I) (510k cleared)

Product code: FMF. Advisory committee: General Hospital. Type: Traditional

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Dec 17, 2025device 510k256d agoEthicon Endo-Surgery, LLC — ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long Stapler (EC3DT45L); ETHICON 3D 45mm White Reload (ER45W); ETHICON 3D 45mm Blue Reload (ER45B); ETHICON 3D 45mm Green Reload (ER45G); ETHICON 3D 45mm Black Reload (ER45T) (510k cleared)

Product code: GDW. Advisory committee: General, Plastic Surgery. Type: Traditional

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Dec 17, 2025device 510k256d agoInari Medical, Inc. — Intri26 Introducer Sheath (510k cleared)Mobia Medical, Inc.

Product code: DYB. Advisory committee: Cardiovascular. Type: Traditional

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Dec 17, 2025device 510k256d agoABBOTT MEDICAL — Amplatzer Piccolo Delivery System (9-PDS-04F-045) (510k cleared)

Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional

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Dec 17, 2025device 510k256d agoNeosoma, Inc. — Neosoma Brain Mets (510k cleared)

Product code: QIH. Advisory committee: Radiology. Type: Traditional

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Dec 17, 2025device pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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 pma256d 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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