SJM BIOCOR VALVE & SUPRA VALVE
FDA premarket approval P040021/S007 · decided 2008-09-26
Approval details
- PMA number
- P040021
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SJM BIOCOR VALVE & SUPRA VALVE
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- ABBOTT MEDICAL
- Date received
- 2008-07-31
- Decision date
- 2008-09-26
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR THE SJM BIOCOR 25MM MITRAL VALVE SIZE AND THE EPIC 25 MM MITRAL VALVE SIZE.
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