Calendar

Week of Sep 22, 2025

Sep 22, 2025device pma332d agoZOLL Medical Corporation — CPR-D-padz Electrode (PMA supplement)

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

Sep 22, 2025device pma332d agoBoston Scientific — Accolade MRI Pacemakers, ESSENTIO MRI (Models L110, L111, L131); PROPONENT MRI (Models L210, L211, L231); ACCOLADE MRI ( (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Sep 22, 2025device pma332d agoZOLL Medical Corporation — CPR Uni-padz Electrode (PMA supplement)

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

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Sep 22, 2025device pma332d agoGuidant Corp. — Accolade Cardiac Resynchronization Therapy Pacemakers, VALITUDE (Model U125); VALITUDE X4 (Model U128); VISIONIST (Model (PMA supplement)Guident Corp.

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

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Sep 22, 2025device pma332d agoABBOTT MEDICAL — Navitor Transcatheter Aortic Valve Implantation System (PMA supplement)

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

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Sep 22, 2025device pma332d agoBoston Scientific Corp — Cardiac Resynchronization Therapy Defibrillators INOGEN (Models G140, G141, G146, G148); DYNAGEN (Models G150, G151, G15 (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Sep 22, 2025device pma332d agoBoston Scientific — Implantable Cardioverter Defibrillator, INOGEN (Models D010, D011, D012, D013, D140, D141, D142, D143); DYNAGEN (Models (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Sep 22, 2025device pma332d agoBoston Scientific Corp — Accolade Non-MRI Pacemakers ALTRUA 2 (Models S701, S702, S722); ESSENTIO (Models L100, L101, L121); PROPONENT (Models (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Sep 22, 2025device recall332d agoBeckman Coulter Inc. device recall (Cls II)

DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. — Reason: Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results. — Status: Ongoing

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Sep 22, 2025device recall332d agoSiemens Healthcare Diagnostics, Inc. device recall (Cls II)

Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6; — Reason: The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples. — Status: Ongoing

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Sep 22, 2025grant332d agoEMORY UNIVERSITY — Impact of Menstruation on Chlamydial and Gonorrhea InfectionEmory University

AI grant. $2,112,000. PI: Alison Swaims Kohlmeier

Week of Sep 22, 2025