CADENCE FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND THE TVL LEAD SYSTEM
FDA premarket approval P910023/S050 · decided 2001-01-18
Approval details
- PMA number
- P910023
- Supplement
- S050
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CADENCE FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND THE TVL LEAD SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2000-12-19
- Decision date
- 2001-01-18
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- USE OF AN ALTERNATE STERILIZATION CHAMBER FOR THE ICDS AND TACHYCARDIA LEADS AND IS ALSO REQUESTING APPROVAL FOR USE OF PARAMETRIC RELEASE AS AN ALTERNATE TO THE CURRENT USE OF BIOLOGICAL INDICATORS IN THE RELEASE OF STERILIZED PRODUCTS.
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