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 | S-ICD GEN 2, S-ICD EMBLEM MRI |
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 | S146 |
Date Received | 09/24/2020 |
Decision Date | 10/01/2020 |
Product Codes |
LWS NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Relocate several manufacturing steps for Tachy, Brady, and S-ICD's. |
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