ST. JUDE MEDICAL BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VALVES
FDA premarket approval P040021/S010 · decided 2009-09-16
Approval details
- PMA number
- P040021
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ST. JUDE MEDICAL BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VALVES
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- ABBOTT MEDICAL
- Date received
- 2009-08-14
- Decision date
- 2009-09-16
- Days to decision
- 33 days
- Decision code
- OK30
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- CHANGE IN RAW MATERIAL USED TO MANUFACTURE THE DEVICE.
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