PMA P060001S049
- Device
- Protégé™ RX Carotid Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P060001
- Supplement
- S049
- Product code
- NIM
- Decision date
- 2025-07-17
- Classification
- Cardiovascular
- Generic name
- Stent, carotid
- Approval order statement
- Approval for implementation of a delivery system manufacturing aid specification change.
Current openFDA PMA Record#
- Device
- Protégé™ RX Carotid Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P060001
- Supplement
- S049
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2025-07-17
- Decision code
- APPR
- Date received
- 2025-06-20
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for implementation of a delivery system manufacturing aid specification change.