|
Device | CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S056 |
Date Received | 09/17/2001 |
Decision Date | 10/15/2001 |
Product Code |
LWS |
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 MINOR UPDATES TO THE DEVICE SOFTWARE FOR THE PHOTON DR ICD (MODEL V-230HV) AND THE PHOTON MICRO (U) VR/DR ICDS (MODELS V-194/V-232) AND MINOR UPDATED TO THE PROGRAMMER SOFTWARE SUPPORTING THE MODEL 3500 AND MODEL 3510 PROGRAMMERS AS WELL AS THE SOFTWARE SUPPORTING THE PR-1500 AND PR-3500 MODEL PROGRAMMERS. |