EverFlex Self-Expanding Peripheral Stent System; EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste
Medtronic Vascular, Inc. · STENT, SUPERFICIAL FEMORAL ARTERY · Cardiovascular
Open FDA's page for this record- PMA number
- P110023
- Supplement number
- S069
- Applicant
- Medtronic Vascular, Inc.
- Street 1
- 3033 Campus Dr.
- City
- Plymouth
- State
- MN
- Zip
- 55441
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Trade name
- EverFlex Self-Expanding Peripheral Stent System; EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste
- Product code
- NIP
- 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
- 2026-09-17
- Decision date
- 2026-10-16
- Decision code
- OK30
- Ao statement
- approval for a sterilization monitoring change to reduce incubation time for the biological indicator used in external process challenge devices
- Harmonized identifiers (openFDA)
- Device name
- Stent, Superficial Femoral Artery
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 2134265, 2020394, 3010155661, 1048735, 1000121056, 2124215, 3011574793, 2183870, 2183744, 3008328690, 1225687, 3009526575, 3006946276, 9681442, 3001845648, 3010273872, 3014656749, 1721676, 3002504068, 3002807090, 1016427, 9616099, 2024168, 3005580113, 9681260, 3010432890, 2017233, 8043892, 1721686, 3010220595, 9681834, 8010026, 1643817, 3004091615, 3011632150, 3005941719, 2939561, 2011171, 3002807314
- FEI number
- 2020394, 3002808327, 3002806368, 3010155661, 1048735, 2828, 1000121056, 3002806565, 2124215, 3011574793, 3003528016, 2183870, 2183744, 3008328690, 3009526575, 3006946276, 3001845648, 3010273872, 3014656749, 3002504068, 1016427, 2024168, 3005580113, 3002095335, 3002807111, 3010432890, 3001451463, 2017233, 1721686, 3006003617, 3010220595, 3004635528, 1643817, 3002808050, 3004091615, 3011632150, 1721676, 2011171, 3002807314