|
Device | COGNIS CARDIAC RESYNCHRONIZATION HE DEFIBRILLATOR |
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 | S207 |
Date Received | 04/17/2009 |
Decision Date | 05/26/2009 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE PROGRAMMER SW MODEL 2868 V1.05 FOR THE TELIGEN AND COGNIS FAMILIES OF DEVICES. |