|
Device | RELIANCE 4-SITE |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S092 |
Date Received | 12/17/2010 |
Decision Date | 02/11/2011 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A DECREASE IN THE LENGTH OF THE POLYURETHANE TUBING PRESENT AT THE PROXIMAL END OF THE LEAD AND A LABELING NOTE REGARDING IMPLANTATION TECHNIQUE. |