PMA P060001S035
- Device
- Protégé GPS Self-Expanding Peripheral Stent System, Protégé RX Carotid Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P060001
- Supplement
- S035
- Product code
- NIM
- Decision date
- 2022-12-15
- Generic name
- Stent, carotid
- Approval order statement
- Addition of a new electropolishing station to the manufacturing process.
Current openFDA PMA Record#
- Device
- Protégé GPS Self-Expanding Peripheral Stent System, Protégé RX Carotid Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P060001
- Supplement
- S035
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2022-12-15
- Decision code
- OK30
- Date received
- 2022-11-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new electropolishing station to the manufacturing process.