PMA P040021S049
- Device
- Epic™, Epic™ Supra and Epic™ Plus Tissue Heart Valves, Biocor™ and Biocor™ Supra Tissue Heart Valves
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040021
- Supplement
- S049
- Product code
- LWR
- Decision date
- 2022-04-14
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Addition of three new tissue suppliers/abbatoirs.
Current openFDA PMA Record#
- Device
- Epic™, Epic™ Supra and Epic™ Plus Tissue Heart Valves, Biocor™ and Biocor™ Supra Tissue Heart Valves
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040021
- Supplement
- S049
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2022-04-14
- Decision code
- OK30
- Date received
- 2022-03-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of three new tissue suppliers/abbatoirs.