PMA P060001S056
- Device
- Protege™ RX Carotid Stent System; Protege™ GPS™ Self-Expanding Peripheral Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P060001
- Supplement
- S056
- Product code
- NIM
- Decision date
- 2026-02-11
- Classification
- Cardiovascular
- Generic name
- Stent, carotid
- Approval order statement
- a new fixture used in the stent microblasting process
Current openFDA PMA Record#
- Device
- Protege™ RX Carotid Stent System; Protege™ GPS™ Self-Expanding Peripheral Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P060001
- Supplement
- S056
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2026-02-11
- Decision code
- OK30
- Date received
- 2026-01-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new fixture used in the stent microblasting process