TVL(TM) Lead System
FDA premarket approval P950022/S145 · decided 2024-03-18
Approval details
- PMA number
- P950022
- Supplement
- S145
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TVL(TM) Lead System
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2024-02-21
- Decision date
- 2024-03-18
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- a change the manufacturing process and to add an alternate silver supplier used on HV leads wire materials
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