PMA P060001S048
- Device
- Protégé RX Carotid Stent System; Protégé GPS Self-expanding Peripheral Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P060001
- Supplement
- S048
- Product code
- NIM
- Decision date
- 2025-05-07
- Classification
- Cardiovascular
- Generic name
- Stent, carotid
- Approval order statement
- removal of a stent Af temperature verification
Current openFDA PMA Record#
- Device
- Protégé RX Carotid Stent System; Protégé GPS Self-expanding Peripheral Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P060001
- Supplement
- S048
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2025-05-07
- Decision code
- OK30
- Date received
- 2025-05-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- removal of a stent Af temperature verification