Biocor Valve, Epic Valve, Epic Supra Valve
FDA premarket approval P040021/S035 · decided 2018-04-19
Approval details
- PMA number
- P040021
- Supplement
- S035
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biocor Valve, Epic Valve, Epic Supra Valve
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-03-27
- Decision date
- 2018-04-19
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Installation of additional data loggers for use with the Vaisala Environmental Monitoring System in the Pampulha, Brazil manufacturing site.
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