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device pma
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Boston Scientific Corp — Vercise Deep Brain Stimulation (DBS) Systems (PMA supplement)

December 17, 2025$BSXupdated 5mo ago
community read0 votes

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

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fda device pma
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same company · ±60 days · 6

  • device pmaBoston Scientific — ESSENTIO MRI (Model L131); PROPONENT MRI (Model L231); ACCOLADE MRI (Model L331) (PMA supplement)Dec 17, 2025
  • device pmaBoston Scientific Corp — Precision Spinal Cord Stimulator (SCS) Systems (PMA supplement)Dec 17, 2025
  • device pmaBoston Scientific Corp — ALTRUA™ 2 (Model S722); ESSENTIO™ (Model L121); PROPONENT™ (Model L221); ACCOLADE™ (Model L321) (PMA supplement)Dec 17, 2025
  • device pmaBoston Scientific Corp — WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Cl (PMA supplement)Dec 18, 2025
  • device pmaBoston Scientific Corp — WaveWriter Alpha Spinal Cord Stimulator (SCS) Mixed Systems, M8 Adaptor (PMA supplement)Dec 18, 2025
  • device pmaBoston Scientific Corp — ALTRUA™ 2 (Models S701, S702, S722) ESSENTIO™ (Models L100, L101, L121) PROPONENT™ (Models L200, L201, L221) ACCOLADE™ ( (PMA supplement)Dec 19, 2025

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