|
Device | RELIANCE IS-1 (PASSIVE) DEFIBRILLATION LEAD |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S309 |
Date Received | 10/09/2012 |
Decision Date | 11/07/2012 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement UPDATES TO TEST METHODS FOR STEROID ELUTING LEADS. |