PMA P140002S006

Device: Misago RX Self-expanding Peripheral Stent
Applicant: Terumo Medical Corporation
PMA number: P140002
Supplement: S006
Product code: NIP
Decision date: 2017-01-05
Classification: Stent, Superficial Femoral Artery
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: Approval for an additional supplier for silicone oil used to lubricate the stent release mechanism of the delivery catheter.

Current openFDA PMA Record#

Device: Misago RX Self-expanding Peripheral Stent
Applicant: Terumo Medical Corporation
PMA number: P140002
Supplement: S006
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2017-01-05
Decision code: APPR
Date received: 2016-09-21
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an additional supplier for silicone oil used to lubricate the stent release mechanism of the delivery catheter.