PMA P060001S026

Device: Protege GPS and Protege RX Carotid Stent System; Protege GPS Self-expanding Peripheral Stent System (Iliac)
Applicant: Medtronic Vascular, Inc.
PMA number: P060001
Supplement: S026
Product code: NIM
Decision date: 2017-11-27
Classification: Stent, Carotid
Generic name: Stent, carotid
Approval order statement: Implement an alternate 7-pallet sterilizer vessel (#71) at the contract sterilizer, Steris Applied Sterilization Technologies.

Current openFDA PMA Record#

Device: Protege GPS and Protege RX Carotid Stent System; Protege GPS Self-expanding Peripheral Stent System (Iliac)
Applicant: Medtronic Vascular, Inc.
PMA number: P060001
Supplement: S026
Product code: NIM
Generic name: Stent, carotid
Decision date: 2017-11-27
Decision code: OK30
Date received: 2017-11-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implement an alternate 7-pallet sterilizer vessel (#71) at the contract sterilizer, Steris Applied Sterilization Technologies.