PMA P030045S011
- Device
- Visi-Pro™ balloon-Expandable peripheral stent system
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P030045
- Supplement
- S011
- Product code
- NIO
- Decision date
- 2026-10-16
- Classification
- Cardiovascular
- Generic name
- STENT, ILIAC
- Approval order statement
- approval for a sterilization monitoring change to reduce incubation time for the biological indicator used in external process challenge devices
Current openFDA PMA Record#
- Device
- Visi-Pro™ balloon-Expandable peripheral stent system
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P030045
- Supplement
- S011
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2026-10-16
- Decision code
- OK30
- Date received
- 2026-09-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a sterilization monitoring change to reduce incubation time for the biological indicator used in external process challenge devices