SJM BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VALVES
FDA premarket approval P040021/S011 · decided 2009-10-02
Approval details
- PMA number
- P040021
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SJM BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VALVES
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- ABBOTT MEDICAL
- Date received
- 2009-08-17
- Decision date
- 2009-10-02
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL, WOODRIDGE FACILITY, ST. PAUL, MINNESOTA FOR BIOBURDEN REDUCTION AND CHEMICAL FIXATION OF THE BIOCOR AND EPIC FAMILY OF HEART VALVES.
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