Biocor/Epic Valves
FDA premarket approval P040021/S039 · decided 2019-03-04
Approval details
- PMA number
- P040021
- Supplement
- S039
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biocor/Epic Valves
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- ABBOTT MEDICAL
- Date received
- 2019-02-13
- Decision date
- 2019-03-04
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Expansion of a controlled access environment room for the manufacture of tissue heart valves and the installation of two new biological safety cabinets at the Abbott Belo Horizonte, Brazil manufacturing site.
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|---|---|---|
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