ST. JUDE MEDICAL BIOCOR VALVE AND BIOCOR SUPRA VALVE
FDA premarket approval P040021/S001 · decided 2006-08-03
Approval details
- PMA number
- P040021
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- ST. JUDE MEDICAL BIOCOR VALVE AND BIOCOR SUPRA VALVE
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- ABBOTT MEDICAL
- Date received
- 2005-09-06
- Decision date
- 2006-08-03
- Days to decision
- 331 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL FOR THE DEVICE.
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