PMA P950022S011
- Device
- TVL LEAD SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P950022
- Supplement
- S011
- Product code
- LWS
- Decision date
- 2000-09-25
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR LEAD PROCESSING AT ST. JUDE MEDICAL, SYLMAR, CALIFORNIA.
Current openFDA PMA Record#
- Device
- TVL LEAD SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P950022
- Supplement
- S011
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2000-09-25
- Decision code
- APPR
- Date received
- 2000-08-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR LEAD PROCESSING AT ST. JUDE MEDICAL, SYLMAR, CALIFORNIA.