CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM
FDA premarket approval P910023/S075 · decided 2005-01-19
Approval details
- PMA number
- P910023
- Supplement
- S075
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 2004-09-08
- Decision date
- 2005-01-19
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR LABELING MODIFICATIONS TO DESCRIBE THE PROTOCOL AND RESULTS FROM THE DEFINITE CLINICAL TRIAL.
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