PMA P030045S009
- Device
- Visi-Pro™ Balloon-Expandable Peripheral Stent System, lntraStent™ DoubleStrut™ Stent
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P030045
- Supplement
- S009
- Product code
- NIO
- Decision date
- 2024-04-05
- Classification
- Cardiovascular
- Generic name
- STENT, ILIAC
- Approval order statement
- a new sterilization cycle with reduced EO concentration using chamber 71 at the contract sterilizer
Current openFDA PMA Record#
- Device
- Visi-Pro™ Balloon-Expandable Peripheral Stent System, lntraStent™ DoubleStrut™ Stent
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P030045
- Supplement
- S009
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2024-04-05
- Decision code
- OK30
- Date received
- 2024-03-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new sterilization cycle with reduced EO concentration using chamber 71 at the contract sterilizer