PMA P970030S001
- Device
- Toronto Spv Valve
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P970030
- Supplement
- S001
- Decision date
- 1998-09-30
Current openFDA PMA Record
- Device
- TORONTO SPV VALVE
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P970030
- Supplement
- S001
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 1998-09-30
- Decision code
- APPR
- Date received
- 1997-12-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Approval order statement
- Approval for the proposed post-approval study protocols submitted in response to fda's conditions of approval, items 1 and 2.