|
Device | EMBLEM S-ICD Pulse Generator and EMBLEM MRI S-ICD Pulse Generator |
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 | S143 |
Date Received | 08/13/2020 |
Decision Date | 10/16/2020 |
Product Codes |
LWS NVY |
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 to allow an additional mold release/de-nest agent to be applied to the polyethylene terephthalate glycol (PETG) sheets used to form sterile packaging. |