PMA P040021S045
- Device
- Biocor, Biocor Supra, Epic and Epic Supra Tissue Heart Valves
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040021
- Supplement
- S045
- Product code
- LWR
- Decision date
- 2020-12-10
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Modifications to the Steady Flow Hydrodynamic Tester.
Current openFDA PMA Record#
- Device
- Biocor, Biocor Supra, Epic and Epic Supra Tissue Heart Valves
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040021
- Supplement
- S045
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2020-12-10
- Decision code
- OK30
- Date received
- 2020-11-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the Steady Flow Hydrodynamic Tester.