|
Device | ENDOTAK RELIANCE AND ENDOTAK ENDURANCE |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S055 |
Date Received | 10/06/2005 |
Decision Date | 11/15/2005 |
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 TO EXTEND THE SHELF LIFE OF THE DRUG PLUG COMPONENT OF THE LEADS FROM ONE YEAR TO THREE YEARS. THE SHELF LIFE OF THE FINISHED LEADS REMAINS TWO YEARS. |