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Device | EMBLEM Subcutaneous Implantable Defibrillator (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 | S137 |
Date Received | 04/09/2020 |
Decision Date | 07/07/2020 |
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 for Model 3877 Programmer SW Application v1.01, updated telemetry firmware for Model 3300 LATITUDE Programmer to support communication with S-ICD devices, and other minor changes. |