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  3. ›device pma
device pma
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Boston Scientific Corp — G124 MOMENTUM™ CRT-D, G125 MOMENTUM™ CRT-D, G126 MOMENTUM™ CRT-D, G128 MOMENTUM, G138 MOMENTUM™ X4 CRT-D, G140 INOGEN™ C (PMA supplement)

October 22, 2025$BSXupdated 5mo ago
community read0 votes

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

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fda device pma
last refreshed 5mo ago
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same company · ±60 days · 6

  • device pmaBoston 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)Oct 22, 2025
  • device pmaBoston Scientific Corporation — A209 SICD Gen 2,A219 SICD MRI (PMA supplement)Oct 22, 2025
  • device pmaBoston Scientific — L110 ESSENTIO™ MRI SR,L111 ESSENTIO™ MRI DR,L131 ESSENTIO™ MRI EL DR,L210 PROPONENT,L211 PROPONENT,L231 PROPONENT,L310 A (PMA supplement)Oct 22, 2025
  • device pmaBoston Scientific Corp — L100 ESSENTIO™ SR,L101 ESSENTIO™ DR,L121 ESSENTIO™ EL DR,L200 PROPONENT™ SR,L201 PROPONENT™ DR,L221 PROPONENT™ EL DR,L30 (PMA supplement)Oct 22, 2025
  • device pmaBoston 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)Oct 22, 2025
  • device pmaBoston 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)Oct 22, 2025

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