TVL LEAD SYSTEM
FDA premarket approval P950022/S011 · decided 2000-09-25
Approval details
- PMA number
- P950022
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- TVL LEAD SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2000-08-17
- Decision date
- 2000-09-25
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR LEAD PROCESSING AT ST. JUDE MEDICAL, SYLMAR, CALIFORNIA.
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