|
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 | S196 |
Date Received | 11/26/2008 |
Decision Date | 12/16/2008 |
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 ENHANCEMENTS TO THE SOFTWARE (VERSION 3.1) USED IN THE ST. JUDE MEDICAL MERLIN.NET SYSTEM. |