|
Device | FORTIFY AND PROMOTE QUANDRA FAMILY OF ICDS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S316 |
Date Received | 05/13/2013 |
Decision Date | 06/12/2013 |
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 ST. JUDE MEDICAL CRMDSYLMAR CA 91342 MODIFICATION OF THE HYBRID POST BURN-IN ATE TESTING FOR THE DEVICES. |