|
Device | AFFINITY/INTREGITY/VICTORY FAMILY PACEMAKERS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S134 |
Date Received | 10/12/2006 |
Decision Date | 10/27/2006 |
Product Code |
NVZ |
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 AN ALTERNATE FEEDTHROUGH SUBSTRATE ON THE VICTORY FAMILY OF PACEMAKERS AND ICD?S. |