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  3. ›device pma
device pma
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Boston Scientific Corp — Epic™ Vascular Self-Expanding Stent System (PMA supplement)

August 8, 2025$BSXupdated 5mo ago
community read0 votes

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

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fda device pma
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same company · ±60 days · 6

  • device pmaBoston Scientific Corp — Eluvia™ Drug-Eluting Vascular Stent System (PMA supplement)Aug 8, 2025
  • device pmaBoston Scientific Corporation — lnnova™ Vascular Self Expanding Stent (PMA supplement)Aug 8, 2025
  • device 510kBoston Scientific Neuromodulation Corporation — GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03) (510k cleared)Aug 7, 2025
  • device recallBoston Scientific Corporation device recall (Cls II)Aug 5, 2025
  • device recallBoston Scientific Corporation device recall (Cls II)Aug 5, 2025
  • device recallBoston Scientific Corporation device recall (Cls II)Aug 5, 2025

🐶 often sniffed alongside

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  • tag510(k) Clearance29 co-mentions · 29 sources
  • company$SLFPFSTANDARD LIFE PLC27 co-mentions · 27 sources
  • company$SLFPYSTANDARD LIFE PLC27 co-mentions · 27 sources
  • tagCardiology15 co-mentions · 13 sources
  • tagUrology12 co-mentions · 10 sources

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