|
Device | EMBLEM S-ICD Programmer Software Application, EMBLEM S-ICD Pulse Generator, 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 | S181 |
Date Received | 03/27/2023 |
Decision Date | 06/15/2023 |
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 software (SW) changes to the EMBLEM subcutaneous implantable cardioverter defibrillator (S-ICD) Programmer SW Application Models 2877 and 3877, and firmware (FW) changes to the EMBLEM Pulse Generator (PG) FW. |