Calendar

Week of Oct 20, 2025

Oct 22, 2025device pma297d agoAbbott Vascular — XIENCE Alpine Everolimus Eluting Coronary Stent System (XIENCE Alpine OTW) (PMA supplement)Postsurgical Therapeutics Inc

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

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Oct 22, 2025device pma297d agoMedtronic, Inc. — Medtronic Evolut PRO+ Delivery Catheter System (PMA supplement)Medtronic plc

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

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Oct 22, 2025device pma297d agoBoston Scientific — L110 ESSENTIO MRI SR,L111 ESSENTIO MRI DR,L131 ESSENTIO MRI EL DR,L210 PROPONENT,L211 PROPONENT,L231 PROPONENT,L310 A (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Oct 22, 2025device pma297d agoLimFlow, Inc. — LimFlow System (PMA supplement)

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

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Oct 22, 2025device pma297d agoCook Ireland, Ltd. — Zilver Flex® 35 Vascular Stent (PMA supplement)

Supplement type: Special (Immediate Track). Product code: NIO. Advisory committee: CV. Decision: APPR

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Oct 22, 2025device pma297d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

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

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Oct 22, 2025device pma297d agoAbbott Vascular, Inc. — Absolute Pro Vascular (PMA supplement)

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

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Oct 22, 2025device pma297d agoOn-X Life Technologies, Inc. — On-X Prosthetic Heart Valves and Ascending Aortic Prothesis (AAP) (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 pma297d agoTransMedics, Inc. — Organ Care System (OCS) Lung System (PMA supplement)TransMedics Group, Inc.

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

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Oct 22, 2025device pma297d agoBoston Scientific — D010 INOGEN MINI ICD VR, D011 INOGEN MINI ICD VR, D012 INOGEN MINI ICD DR, D013 INOGEN MINI ICD DR, D020 DYNAGEN MI (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Oct 22, 2025device pma297d agoOn-X Life Technologies, Inc. — On-X Prosthetic Heart Valves and 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 pma297d agoTransMedics, Inc. — Organ Care System (OCS) Liver (PMA supplement)TransMedics Group, Inc.

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

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Oct 22, 2025device pma297d agoBoston Scientific Corporation — A209 SICD Gen 2,A219 SICD MRI (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 pma297d 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 pma297d 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 pma297d 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 pma297d 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 pma297d 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 pma297d 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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