|
Device | Emblem Subcutaneous Implantable Cardioverter Defibrillator Pulse Gerator |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC CORPORATION 4100 HAMLINE AVENUE NORTH ST. PAUL, MN 55112-5798 |
PMA Number | P110042 |
Supplement Number | S087 |
Date Received | 06/07/2017 |
Decision Date | 08/08/2017 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a higher density insulation paper in the high voltage capacitors and associated manufacturing process changes. |