|
Device | CADENCE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S141 |
Date Received | 05/07/2007 |
Decision Date | 06/06/2007 |
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 ENHANCEMENTS IN THE MANUFACTURE OF THE HIGH VOLTAGE CAPACITOR USED IN THE DEVICE. |