|
Device | CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S109 |
Date Received | 05/09/2006 |
Decision Date | 06/20/2006 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ENHANCEMENTS TO THE DATA PROCESSING USED FOR THE ST. JUDE MEDICAL HOUSECALL PLUS SYSTEM. |