|
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 | S038 |
Date Received | 06/12/2014 |
Decision Date | 04/09/2015 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO ADD AN ADDITIONAL STERILIZATION FACILITY AND BACK-UP FACILITY AS WELL AS CHANGES IN THE CYCLE PARAMETERS. |