PMA P040021S047
- Device
- Epic, Epic Supra and Epic Plus Tissue Heart Valves
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040021
- Supplement
- S047
- Product code
- LWR
- Decision date
- 2021-09-17
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Approval for a modification to the sewing cuff components intended to increase valve radiopacity.
Current openFDA PMA Record#
- Device
- Epic, Epic Supra and Epic Plus Tissue Heart Valves
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040021
- Supplement
- S047
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2021-09-17
- Decision code
- APPR
- Date received
- 2021-06-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a modification to the sewing cuff components intended to increase valve radiopacity.