INSPIRIS RESILIA Aortic Valve; MITRIS RESILIA Mitral Valve
Edwards Lifesciences, LLC · heart-valve, non-allograft tissue · Cardiovascular
Open FDA's page for this record- PMA number
- P150048
- Supplement number
- S100
- Applicant
- Edwards Lifesciences, LLC
- Street 1
- One Edwards Way
- City
- Irvine
- State
- CA
- Zip
- 92614
- Generic name
- heart-valve, non-allograft tissue
- Trade name
- INSPIRIS RESILIA Aortic Valve; MITRIS RESILIA Mitral Valve
- Product code
- LWR
- Advisory committee
- CV
- Advisory committee description
- Cardiovascular
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited review flag
- N
- Date received
- 2026-04-17
- Decision date
- 2026-10-22
- Decision code
- APPR
- Ao statement
approval for a manufacturing site located at CENTERPIECE (Bulevar La Encantada Industrial, Parque Industrial El Floride, Seccion La Encantada # 11530, Tijuana Baja California, Mexico 22250) for terminal ethylene oxide sterilization.
- Harmonized identifiers (openFDA)
- Device name
- Heart-Valve, Non-Allograft Tissue
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 3015287573, 3005687633, 2030624, 3001883144, 2025587, 3007063218, 2183744, 3002806603, 3007113487, 3004478276, 3010421104, 3014918977, 3010432890, 2015691, 9612515, 3044156918, 3012179728, 3008500478, 2135147, 1721676, 9617601, 2011171
- FEI number
- 3015287573, 3005687633, 3001883144, 2025587, 3007063218, 2183744, 1713910, 3002806603, 3007113487, 3004478276, 3002808437, 3005334138, 3010421104, 3014918977, 3000206435, 3010432890, 2015691, 3044156918, 3012179728, 3002534070, 1721676, 2011171