Calendar

Week of Oct 13, 2025

Oct 16, 2025device 510k304d agoMode Sensors AS — Re:Balans (510k cleared)

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

Oct 16, 2025device 510k304d agoSHENZHEN SUPERLINE TECHNOLOGY CO., LTD. — Alpha Endo Handpiece (Alpha Endo) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

Product code: EKX. Advisory committee: Dental. Type: Traditional

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Oct 16, 2025device 510k304d agoPenumbra, Inc. — INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing (510k cleared)Penumbra Inc

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

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Oct 16, 2025device 510k304d agoArthrex, Inc. — Arthrex Synergy Vision Imaging System (510k cleared)

Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional

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Oct 16, 2025device 510k304d agoRiverpoint Medical — ProZip Knotless Implant (510k cleared)

Product code: GAT. Advisory committee: General, Plastic Surgery. Type: Special

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Oct 16, 2025device 510k304d agoSc Medica — FFX Facet Fixation System (510k cleared)

Product code: MRW. Advisory committee: Unknown. Type: Traditional

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Oct 16, 2025device 510k304d agoMatelaser, Inc. — MateLaser Medical Diode Laser Systems (ML-DLS-30) (510k cleared)

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

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Oct 16, 2025device 510k304d agoAsterasys Co., Ltd. — Coolfase (510k cleared)

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

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Oct 16, 2025device 510k304d agoMaxigen Biotech, Inc. — SurgiAid Collagen Wound Dressing (HA) (510k cleared)NKGen Biotech Inc

Product code: KGN. Advisory committee: Unknown. Type: Traditional

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Oct 16, 2025device pma304d agoVascutek, Ltd. — Thoraflex Hybrid (PMA supplement)

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

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Oct 16, 2025device pma304d agoCochlear Americas — Nucleus® 24 Cochlear Implant System (PMA supplement)

Supplement type: Real-Time Process. Product code: MCM. Advisory committee: EN. Decision: APPR

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Oct 16, 2025device pma304d 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 16, 2025device pma304d agoMedtronic Minimed — Guardian Connect System Simplera System (PMA supplement)

Supplement type: 30-Day Notice. Product code: MDS. Advisory committee: CH. Decision: OK30

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Oct 16, 2025device pma304d agoEdwards Lifesciences, LLC — INSPIRIS RESILIA Aortic Valve; MITRIS RESILIA Mitral Valve (PMA supplement)Edwards Lifesciences Corp

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

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Oct 16, 2025device pma304d agoCochlear Americas — Nucleus® Hybrid L24 Cochlear Implant System (PMA supplement)

Supplement type: Real-Time Process. Product code: PGQ. Advisory committee: EN. Decision: APPR

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Oct 16, 2025device pma304d agoEdwards Lifesciences, LLC — Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis; Carpentier-Edwards PERIMOUNT Plus Mitral Bioprosthesi (PMA supplement)Edwards Lifesciences Corp

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

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Oct 16, 2025device pma304d agoBiotronik, Inc. — Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149, Enitra 6 DR- (PMA supplement)

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

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Oct 16, 2025device pma304d agoMedtronic Minimed — Medtronic MiniMed 630G System (PMA supplement)

Supplement type: 30-Day Notice. Product code: OZO. Advisory committee: CH. Decision: OK30

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Oct 16, 2025device pma304d agoBiotronik, Inc. — Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Intica 7 VR-T 404634; I (PMA supplement)

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

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Oct 16, 2025device pma304d agoEdwards Lifesciences, LLC — EDWARDS INTUITY Elite Valve (PMA supplement)Edwards Lifesciences Corp

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

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Oct 16, 2025device pma304d agoMedtronic Minimed, Inc. — Simplera Sync Sensor, Guardian 4 Sensor (PMA supplement)Medtronic USA Inc

Supplement type: 30-Day Notice. Product code: SFI. Advisory committee: CH. Decision: OK30

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Oct 16, 2025device pma304d agoBiotronik, Inc. — Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569 (PMA supplement)

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

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Oct 16, 2025device pma304d agoFerring Pharmaceuticals, Inc. — EUFLEXXA® (1% SODIUM HYALURONATE) (PMA supplement)Ferring Pharmaceuticals Inc

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

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Oct 16, 2025device pma304d agoABBOTT MEDICAL — FlexAbility Ablation Catheter, Sensor Enabled (PMA supplement)

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

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Oct 16, 2025device pma304d agoMedtronic Minimed, Inc. — MiniMed 670G System; MiniMed 770G System; MiniMed 780G System (PMA supplement)Medtronic USA Inc

Supplement type: 30-Day Notice. Product code: OZP. Advisory committee: CH. Decision: OK30

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Oct 16, 2025device pma304d agoBiotronik, Inc. — Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568 (PMA supplement)

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

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Oct 16, 2025device pma304d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3 Transcatheter Heart Valve (PMA supplement)Edwards Lifesciences Corp

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

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Oct 16, 2025device pma304d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3 Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra RES (PMA supplement)Edwards Lifesciences Corp

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

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Oct 16, 2025device pma304d agoMedtronic Neuromodulation — InterStim® Therapy System, Verify® Evaluation System (PMA supplement)

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

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Oct 16, 2025device pma304d agoCarl Zeiss Meditec, Inc. — VISUMAX 800 Femtosecond Laser (PMA supplement)

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

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Oct 16, 2025device pma304d agoMedtronic, Inc. — SynchroMed Infusion System, Ascenda Intrathecal Catheters (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30

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Oct 16, 2025device pma304d agoMedtronic Neuromodulation — InterStim® Therapy System, Verify® Evaluation System (PMA supplement)

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

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Oct 16, 2025device pma304d agoBiotronik, Inc. — Edora 8 HF-T QP 407137 Edora 8 HF-T 407138 Evity 8 HF-T QP 407139 Evity 8 HF-T 407140 Enitra 8 HF-T QP 407141 Enitra 8 H (PMA supplement)

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

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Oct 16, 2025device pma304d agoMedtronic Neuromodulation — Restore, Itrel®, Synergy IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and (PMA supplement)

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

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Oct 16, 2025device recall304d agoCanon Medical System, USA, INC. device recall (Cls II)

VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. — Reason: Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment. — Status: Ongoing

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Oct 16, 2025device recall304d agoSHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION device recall (Cls II)

Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the X-ray tube unit. This unit is used for radiographic examinations of whole body except mammography when combined with an X-ray high voltage generator, an X-ray tube unit, an X-ray collimator, and if necessary, an X-ray radiography stand, an X-ray radiography table, and digital radiography system. — Reason: Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft. — Status: Ongoing

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Oct 17, 2025approval303d agoVYVGART HYTRULO (EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC) — FDA approvalARGENX SE

Sponsor: ARGENX BV. Form: INJECTABLE. Route: INJECTION

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Oct 17, 2025approval303d agoOZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: TABLET. Route: ORAL

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Oct 17, 2025approval303d agoOZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: TABLET. Route: ORAL

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Oct 17, 2025approval303d agoOZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: TABLET. Route: ORAL