PMA P060001S030
- Device
- Protégé GPS Self-Expanding Peripheral Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P060001
- Supplement
- S030
- Product code
- NIM
- Decision date
- 2020-08-18
- Generic name
- Stent, carotid
- Approval order statement
- Addition of an equivalent CNC machine 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
- S030
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2020-08-18
- Decision code
- OK30
- Date received
- 2020-07-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an equivalent CNC machine at a supplier for a catheter component.