PMA P110023S024

Device: EverFlex Self-Expanding Peripheral Stent System; EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System;
Applicant: Medtronic Vascular, Inc.
PMA number: P110023
Supplement: S024
Product code: NIP
Decision date: 2017-11-27
Classification: Stent, Superficial Femoral Artery
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: Implement an alternate 7-pallet sterilizer vessel (#71) at the contract sterilizer, Steris Applied Sterilization Technologies.

Current openFDA PMA Record#

Device: EverFlex Self-Expanding Peripheral Stent System; EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System;
Applicant: Medtronic Vascular, Inc.
PMA number: P110023
Supplement: S024
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
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.