|
Device | 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 | S020 |
Date Received | 11/06/2013 |
Decision Date | 01/31/2014 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW BATTERY SUPPLIER FOR THE SQ-RX MODEL 1010 IMPLANTABLE PULSE GENERATOR. |