Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | EMBLEM S-ICD System |
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 | S132 |
Date Received | 12/23/2019 |
Decision Date | 03/20/2020 |
Product Codes |
LWS NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for alternate hardware components and design modifications (with associated manufacturing changes), firmware update to version 3.1.543 (Models A209/A219), and software to version 4.08 (Model 2877). |
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