|
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 | S142 |
Date Received | 05/21/2007 |
Decision Date | 07/10/2007 |
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 SOFTWARE MODIFICATIONS TO THE HOUSECALL PLUS SYSTEM SOFTWARE (RECEIVER SOFTWARE MODEL 4000 VERSION 3.1) WHICH MERGES THE HOUSECALL RECEIVER 3.0.3 AND THE MATRIX PCS 2.0 SOFTWARE VERSION. |