- Device
- Epic™ Plus, Epic™ Plus Supra, Epic™ Max, Epic™ Elite, Epic™ Supra G3 Tissue Heart Valves
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040021
- Supplement
- S063
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2026-09-18
- Decision code
- OK30
- Date received
- 2026-08-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- removal of the destructive pinch inspection at receiving (applicable to Epic Elite and Epic Supra G3 only) and the addition of a new non-destructive stent pinch inspection as a 100% in-process control for all Epic valves