Epic Plus, Epic Plus Supra, Epic Max, Epic Elite, Epic Supra G3 Tissue Heart Valves
ABBOTT MEDICAL · heart-valve, non-allograft tissue · Cardiovascular
Open FDA's page for this record- PMA number
- P040021
- Supplement number
- S063
- Applicant
- ABBOTT MEDICAL
- Street 1
- 177 County Rd. B E.
- City
- St. Paul
- State
- MN
- Zip
- 55117
- Generic name
- heart-valve, non-allograft tissue
- Trade name
- Epic Plus, Epic Plus Supra, Epic Max, Epic Elite, Epic Supra G3 Tissue Heart Valves
- Product code
- LWR
- Advisory committee
- CV
- Advisory committee description
- Cardiovascular
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited review flag
- N
- Date received
- 2026-08-18
- Decision date
- 2026-09-18
- Decision code
- OK30
- Ao 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
- Harmonized identifiers (openFDA)
- Device name
- Heart-Valve, Non-Allograft Tissue
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 3012179728, 2025587, 3015287573, 3010432890, 3001883144, 2015691, 3010421104, 1721676, 3014918977, 2183744, 2011171, 3002806603, 9612515, 3007113487, 3007063218, 9617601, 3044156918, 3005687633, 3008500478, 3004478276, 2135147, 2030624
- FEI number
- 3012179728, 2025587, 3015287573, 3005334138, 3010432890, 3001883144, 2015691, 3002808437, 3010421104, 1721676, 3014918977, 2183744, 3002534070, 2011171, 3002806603, 3007113487, 3000206435, 3007063218, 3044156918, 3005687633, 1713910, 3004478276