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device pma
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Boston Scientific — Accolade MRI Pacemakers- ACCOLADE MRI Models: L310, L311, L331; ESSENTIO MRI Models: L110, L111, L131; PROPONENT Models: (PMA supplement)

January 8, 2026$BSXupdated 5mo ago
community read0 votes

Supplement type: 135 Review Track For 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: APPR

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fda device pma
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same company · ±60 days · 6

  • device pmaBoston Scientific Corporation — ENROUTE Transcarotid Stent System (PMA supplement)Jan 8, 2026
  • device pmaBoston Scientific Corp — NG3 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds): DYNAGEN Models: G150, G151, G154, G156, G158; INOGEN Mode (PMA supplement)Jan 8, 2026
  • device pmaBoston Scientific Corp — Accolade Pacemakers: ACCOLADE Models: L300, L301, L321; ALTRUA 2 Models: S701, S702, S722; ESSENTIO Models: L100, L101, (PMA supplement)Jan 8, 2026
  • device pmaBoston Scientific — NG3 Implantable Cardioverter Defibrillators (ICDs): DYNAGEN Models: D020, D021, D022, D023, D150, D151, D152, D153; INOG (PMA supplement)Jan 8, 2026
  • device pmaBoston Scientific Corporation — Subcutaneous Implantable Cardioverter Defibrillator (S-ICD): EMBLEM S-ICD Model A209 and EMBLEM MRI S-ICD Model A219 (PMA supplement)Jan 8, 2026
  • device pmaBoston Scientific — INGEVITY™ Family Bradycardia Leads (PMA supplement)Jan 9, 2026

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