PMA P980033S040

Device: WALLSTENT SYSTEM (10 MM VENOUS ENDOPROSTHESIS) AND UNISTEP PLUS DELIVERY SYSTEM (12 MM VENOUS ENDOPROSTHESIS)
Applicant: Boston Scientific Corporation
PMA number: P980033
Supplement: S040
Product code: QKJ
Decision date: 2013-12-18
Classification: Stent, Coronary
Generic name: Stent, central venous
Approval order statement: CHANGE TO IMPLEMENT A LASERLINC MEASUREMENT SYSTEM FOR MEASURING AND SORTING EXTRUDED COMPONENTS.

Current openFDA PMA Record#

Device: WALLSTENT SYSTEM (10 MM VENOUS ENDOPROSTHESIS) AND UNISTEP PLUS DELIVERY SYSTEM (12 MM VENOUS ENDOPROSTHESIS)
Applicant: Boston Scientific Corporation
PMA number: P980033
Supplement: S040
Product code: QKJ
Generic name: Stent, central venous
Decision date: 2013-12-18
Decision code: OK30
Date received: 2013-11-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO IMPLEMENT A LASERLINC MEASUREMENT SYSTEM FOR MEASURING AND SORTING EXTRUDED COMPONENTS.