PMA P060001S047
- Device
- PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P060001
- Supplement
- S047
- Product code
- NIM
- Decision date
- 2025-05-09
- Classification
- Cardiovascular
- Generic name
- Stent, carotid
- Approval order statement
- approval for a change to the pressed tantalum sphere visual inspection acceptance criteria
Current openFDA PMA Record#
- Device
- PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P060001
- Supplement
- S047
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2025-05-09
- Decision code
- OK30
- Date received
- 2025-04-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a change to the pressed tantalum sphere visual inspection acceptance criteria