PMA P060001S033
- Device
- Protege RX Carotid Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P060001
- Supplement
- S033
- Product code
- NIM
- Decision date
- 2022-05-23
- Generic name
- Stent, carotid
- Approval order statement
- Approval for increasing the tolerance of the delivery system component.
Current openFDA PMA Record#
- Device
- Protege RX Carotid Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P060001
- Supplement
- S033
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2022-05-23
- Decision code
- APPR
- Date received
- 2022-03-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for increasing the tolerance of the delivery system component.