PMA P030045S010
- Device
- Visi-Pro™ Balloon-expandable Peripheral Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P030045
- Supplement
- S010
- Product code
- NIO
- Decision date
- 2024-07-26
- Classification
- Cardiovascular
- Generic name
- STENT, ILIAC
- Approval order statement
- updating in-process inspections for burst testing and inflation lumen
Current openFDA PMA Record#
- Device
- Visi-Pro™ Balloon-expandable Peripheral Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P030045
- Supplement
- S010
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2024-07-26
- Decision code
- OK30
- Date received
- 2024-07-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- updating in-process inspections for burst testing and inflation lumen