|
Device | ENDOTAK RELIANCE 4-SITE DEFIBRILLATION LEADS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S128 |
Date Received | 09/03/2014 |
Decision Date | 11/04/2014 |
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 | Yes |
Approval Order Statement APPROVAL FOR THE ACUITY X4 CONNECTOR TOOL MODEL 4625 ACCESSORY. |