|
Device | COGNIS PULSE GENERATORS |
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 | S245 |
Date Received | 07/13/2010 |
Decision Date | 08/06/2010 |
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 MODIFICATIONS TO THE FRONT LINER COMPONENT USED ON THE TELIGEN AND COGNIS PULSE GENERATORS IN THE HYBRID ASSEMBLY AND TO REMOVE THE POLYIMIDE TAPE CURRENTLY APPLIED OVER THE ACCELEROMETER COMPONENT. |