- Device
- Protégé RX Self-expanding Stent System, Protégé GPS Self-Expanding Peripheral Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P060001
- Supplement
- S032
- Product code
- NIM
- Generic name
- Stent, carotid
- 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.