PMA P060001S054
- Device
- Protégé RX Carotid Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P060001
- Supplement
- S054
- Product code
- NIM
- Decision date
- 2026-01-23
- Classification
- Cardiovascular
- Generic name
- Stent, carotid
- Approval order statement
- a new sub-tier supplier for stamping/die cutting process of silicone seals
Current openFDA PMA Record#
- Device
- Protégé RX Carotid Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P060001
- Supplement
- S054
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2026-01-23
- Decision code
- OK30
- Date received
- 2026-01-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new sub-tier supplier for stamping/die cutting process of silicone seals