PMA P970030S003
- Device
- ST JUDE TORONTO SPV VALVE
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P970030
- Supplement
- S003
- Product code
- LWR
- Decision date
- 2000-01-06
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Six manufacturing process chemical solution changes used in the production of the St. Jude Medical Toronto SPV Valve.
Current openFDA PMA Record
- Device
- ST JUDE TORONTO SPV VALVE
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P970030
- Supplement
- S003
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2000-01-06
- Decision code
- OK30
- Date received
- 1999-12-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Six manufacturing process chemical solution changes used in the production of the St. Jude Medical Toronto SPV Valve.