PMA P060001S028
- Device
- Protégé GPS and Protégé RX Carotid Stent Systems, and Protégé GPS Peripheral Stent Systems
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P060001
- Supplement
- S028
- Product code
- NIM
- Decision date
- 2019-06-17
- Classification
- Stent, Carotid
- Generic name
- Stent, carotid
- Approval order statement
- Alternate manufacturing facility for an existing supplier.
Current openFDA PMA Record#
- Device
- Protégé GPS and Protégé RX Carotid Stent Systems, and Protégé GPS Peripheral Stent Systems
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P060001
- Supplement
- S028
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2019-06-17
- Decision code
- OK30
- Date received
- 2019-05-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate manufacturing facility for an existing supplier.