PMA P040021S046
- Device
- Epic and Epic Supra Tissue Heart Valves
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040021
- Supplement
- S046
- Product code
- LWR
- Decision date
- 2021-05-28
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Approval for labeling changes related to future valve-in-valve procedures.
Current openFDA PMA Record#
- Device
- Epic and Epic Supra Tissue Heart Valves
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040021
- Supplement
- S046
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2021-05-28
- Decision code
- APPR
- Date received
- 2021-04-30
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling changes related to future valve-in-valve procedures.