CADENCE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
FDA premarket approval P910023/S141 · decided 2007-06-06
Approval details
- PMA number
- P910023
- Supplement
- S141
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CADENCE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2007-05-07
- Decision date
- 2007-06-06
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- ENHANCEMENTS IN THE MANUFACTURE OF THE HIGH VOLTAGE CAPACITOR USED IN THE DEVICE.
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