CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM
FDA premarket approval P910023/S056 · decided 2001-10-15
Approval details
- PMA number
- P910023
- Supplement
- S056
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2001-09-17
- Decision date
- 2001-10-15
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- 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.
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