|
Device | AFFINITY/INTEGRITY/VICTORY FAMILIES OF PACEMAKERS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S168 |
Date Received | 09/02/2008 |
Decision Date | 10/01/2008 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF AN END OF LIFE (EL) COMMUNICATION SOFTWARE TEST TO THE AUTOMATED MANUFACTURING SOFTWARE TEST SUITE USED DURING HYBRID MANUFACTURING. |