PMA P980001S004

Device: NIR ON RANGER AND NIR ON RANGER WITH/SOX
Applicant: Boston Scientific Corp
PMA number: P980001
Supplement: S004
Decision date: 1999-03-10
Approval order statement: Approval for a change in the specification of the balloon component for the NIR ON(TM) Ranger(TM) Premounted Stent System. This change applies only to the 9 mm length NIR ON(TM) Ranger(TM) Premounted Stent System with the 3.0mm, 3.5mm and 4.0mm balloon diameters.

Current openFDA PMA Record

Device: NIR ON RANGER AND NIR ON RANGER WITH/SOX
Applicant: Boston Scientific Corp
PMA number: P980001
Supplement: S004
Decision date: 1999-03-10
Decision code: APPR
Date received: 1999-02-09
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a change in the specification of the balloon component for the NIR ON(TM) Ranger(TM) Premounted Stent System. This change applies only to the 9 mm length NIR ON(TM) Ranger(TM) Premounted Stent System with the 3.0mm, 3.5mm and 4.0mm balloon diameters.