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Device | EMBLEM S-ICD PG models A209 and A219. |
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 | S160 |
Date Received | 09/20/2021 |
Decision Date | 10/19/2021 |
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 Add second suppliers for the PCB and RF Crystal components; modification to the manufacturing material of the RF Crystal component from the new supplier, and correction to design specification for the EMBLEM S-ICD PG models A209 and A219. |