PMA P060001S053
- Device
- Protégé™ GPS™ Self-expanding Peripheral Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P060001
- Supplement
- S053
- Product code
- NIM
- Decision date
- 2025-12-16
- Classification
- Cardiovascular
- Generic name
- Stent, carotid
- Approval order statement
- to modify the injection overmolding process parameters at a supplier for a catheter component
Current openFDA PMA Record#
- Device
- Protégé™ GPS™ Self-expanding Peripheral Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P060001
- Supplement
- S053
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2025-12-16
- Decision code
- OK30
- Date received
- 2025-12-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to modify the injection overmolding process parameters at a supplier for a catheter component