|
Device | SUBCUTANEOUS IMPLANABLE 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 | S016 |
Date Received | 09/03/2013 |
Decision Date | 10/31/2013 |
Product Code |
LWS |
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 A SUPPLIER CHANGE FOR THE HIGH VOLTAGE CAPACITORS USED IN THE S-ICD SYSTEM. |