PMA P970030
- Device
- ST JUDE MEDICAL TORONTO SPV VALVE, MODEL SPA-101
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P970030
- Supplement
- S003
- Product code
- LWR
- Decision date
- 2006-03-31
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- APPROVAL FOR CHANGES TO THE INSTRUCTION FOR USE TO ADD AND STRENGTHEN CAUTIONS IN THE USE OF THE DEVICE.
Current openFDA PMA Record#
- Device
- ST JUDE MEDICAL TORONTO SPV VALVE, MODEL SPA-101
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P970030
- Supplement
- S006
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2006-03-31
- Decision code
- APPR
- Date received
- 2006-03-03
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE INSTRUCTION FOR USE TO ADD AND STRENGTHEN CAUTIONS IN THE USE OF THE DEVICE.