PMA P040021
- Device
- Epic™, Epic™ Supra, Epic™ Plus, Epic™ Plus Supra and Epic™ Max, Epic™ Elite, and Epic™ Supra G3 Stented Tissue Valves
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040021
- Supplement
- S051
- Product code
- LWR
- Decision date
- 2026-08-11
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- additional abattoirs for porcine and bovine tissue sourcing
Current openFDA PMA Record#
- Device
- Epic™, Epic™ Supra, Epic™ Plus, Epic™ Plus Supra and Epic™ Max, Epic™ Elite, and Epic™ Supra G3 Stented Tissue Valves
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040021
- Supplement
- S062
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2026-08-11
- Decision code
- OK30
- Date received
- 2026-07-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- additional abattoirs for porcine and bovine tissue sourcing