|
Device | MULTICETER AUTOMATIC DEFIBRILLATOR IMPLANT ATION YTRIAL WITH CARDIAC RESYNCHRONIZATION THERAPY |
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 | S270 |
Date Received | 07/29/2011 |
Decision Date | 09/27/2011 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR POST- APPROVAL STUDY PROTOCOL. |