CADENCE (R) TIERED THERAPY DEFIBRILLATOR SYSTEM
FDA premarket approval P910023/S079 · decided 2005-05-09
Approval details
- PMA number
- P910023
- Supplement
- S079
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CADENCE (R) TIERED THERAPY DEFIBRILLATOR SYSTEM
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 2005-04-22
- Decision date
- 2005-05-09
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- ALTERNATE PROCESS FOR REMOVING EPOXY FROM THE CONNECTOR BLOCK THREADED BORES OF THE ICD DEVICES.
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