|
Device | RELIANCE IS-1/DF-1 LEAD AND RELIANCE 4-SITE LEAD |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S116 |
Date Received | 03/19/2013 |
Decision Date | 05/07/2013 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR AN ALTERNATE PRIMER MATERIAL FOR THE FLEXTEND AND ACTIVE FIXATION RELIANCE IS-1/4-SITE LEADS. |