PMA P060001S016
- Device
- PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P060001
- Supplement
- S016
- Product code
- NIM
- Decision date
- 2012-01-18
- Classification
- Stent, Carotid
- Generic name
- Stent, carotid
- Approval order statement
- ADDITION OF A 7-PALLET STERILIZER VESSEL AT THE CONTRACT STERILIZER.
Current openFDA PMA Record#
- Device
- PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P060001
- Supplement
- S016
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2012-01-18
- Decision code
- OK30
- Date received
- 2011-12-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A 7-PALLET STERILIZER VESSEL AT THE CONTRACT STERILIZER.