Visi-Pro balloon-Expandable peripheral stent system
Medtronic Vascular, Inc. · STENT, ILIAC · Cardiovascular
Open FDA's page for this record- PMA number
- P030045
- Supplement number
- S011
- Applicant
- Medtronic Vascular, Inc.
- Street 1
- 3033 Campus Dr.
- City
- Plymouth
- State
- MN
- Zip
- 55441
- Generic name
- STENT, ILIAC
- Trade name
- Visi-Pro balloon-Expandable peripheral stent system
- Product code
- NIO
- 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, Iliac
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 2134265, 2020394, 1000121056, 2124215, 3011574793, 2183870, 2183744, 2024024, 1225687, 1058584, 3009526575, 9681442, 3001845648, 3010273872, 3014656749, 3002504068, 3002807090, 1016427, 9616099, 2024168, 3005580113, 9681260, 9616666, 8043892, 3005111382, 3010220595, 9681834, 8010026, 1018233, 1643817, 3004091615, 1531050, 3005941719, 3006082230, 2939561, 3005718570, 3002807314
- FEI number
- 2020394, 3002808327, 3002806368, 1000219637, 2828, 1000121056, 3002806565, 2124215, 3011574793, 3002755653, 3003528016, 2183870, 2183744, 2024024, 3009526575, 3001845648, 3010273872, 3014656749, 3002504068, 1016427, 2024168, 3005580113, 3002095335, 3002807111, 3001451463, 3006003617, 3005111382, 3010220595, 3008906816, 3004635528, 1018233, 1643817, 3002808050, 3004091615, 3006082230, 3005718570, 3002807314