PMA P030045S006
- Device
- lntraStent DoubleStrut Stent, Visi-Pro Balloon-Expandable Peripheral Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P030045
- Supplement
- S006
- Product code
- NIO
- Decision date
- 2021-05-07
- Generic name
- STENT, ILIAC
- Approval order statement
- New sterilization cycle with a reduced EO concentration using Chamber 31 and Chamber 32 at contract sterilizer.
Current openFDA PMA Record#
- Device
- lntraStent DoubleStrut Stent, Visi-Pro Balloon-Expandable Peripheral Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P030045
- Supplement
- S006
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2021-05-07
- Decision code
- OK30
- Date received
- 2021-04-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New sterilization cycle with a reduced EO concentration using Chamber 31 and Chamber 32 at contract sterilizer.