PMA P140002S019

Device: MISAGO RX Self-expanding Peripheral Stent
Applicant: Terumo Medical Corporation
PMA number: P140002
Supplement: S019
Product code: NIP
Decision date: 2019-07-26
Classification: Stent, Superficial Femoral Artery
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: Approval for modifications to the sterilization cycle parameters, loading configuration, and requirements for product release from the sterilization process.

Current openFDA PMA Record#

Device: MISAGO RX Self-expanding Peripheral Stent
Applicant: Terumo Medical Corporation
PMA number: P140002
Supplement: S019
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2019-07-26
Decision code: APPR
Date received: 2018-12-19
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for modifications to the sterilization cycle parameters, loading configuration, and requirements for product release from the sterilization process.