PMA P030045S004

Device: IntraStent DoubleStrut Stent; Visi-Pro Balloon-Expandable Peripheral Stent System (Ilac)
Applicant: Medtronic Vascular, Inc.
PMA number: P030045
Supplement: S004
Product code: NIO
Decision date: 2017-11-27
Classification: Stent, Iliac
Generic name: STENT, ILIAC
Approval order statement: Implement an alternate 7-pallet sterilizer vessel (#71) at the contract sterilizer, Steris Applied Sterilization Technologies.

Current openFDA PMA Record#

Device: IntraStent DoubleStrut Stent; Visi-Pro Balloon-Expandable Peripheral Stent System (Ilac)
Applicant: Medtronic Vascular, Inc.
PMA number: P030045
Supplement: S004
Product code: NIO
Generic name: STENT, ILIAC
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.