PMA P040021S022
- Device
- ST. JUDE MEDICAL BIOCOR AND BIOCOR SUPRA VALVES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040021
- Supplement
- S022
- Product code
- LWR
- Decision date
- 2012-08-30
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- ST. JUDE MEDICAL BIOCOR AND BIOCOR SUPRA VALVES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040021
- Supplement
- S022
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2012-08-30
- Decision code
- APPR
- Date received
- 2012-04-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.