PMA P980001S008

Device: NIR PRIMO PREMOUNTED STENT SYSTEM
Applicant: Boston Scientific Corp
PMA number: P980001
Supplement: S008
Decision date: 1999-06-11
Approval order statement: Approval for a change in the specification of the balloon component for the NIR(TM) Primo(TM) Premounted Stent System. This change applies only to the 9 mm length NIR(TM) Primo(TM) Premounted Stent System with the 3.0 mm, 3.5 mm, and 4.0 mm balloon diameters.

Current openFDA PMA Record

Device: NIR PRIMO PREMOUNTED STENT SYSTEM
Applicant: Boston Scientific Corp
PMA number: P980001
Supplement: S008
Decision date: 1999-06-11
Decision code: APPR
Date received: 1999-05-10
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(TM) Primo(TM) Premounted Stent System. This change applies only to the 9 mm length NIR(TM) Primo(TM) Premounted Stent System with the 3.0 mm, 3.5 mm, and 4.0 mm balloon diameters.