PMA P100023S008

Device: ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY SYSTEM
Applicant: Boston Scientific Corp
PMA number: P100023
Supplement: S008
Product code: NIQ
Decision date: 2011-07-27
Generic name: Coronary drug-eluting stent
Approval order statement: ALTERNATE INHERENT VISCOSITY TEST METHOD FOR TESTING OF AESON-BLENDED RESIN AND ANNEALED GRADIENT OUTER TUBING COMPONENT, AND AN UPDATE OF ASSOCIATED SPECIFICATIONS.

Current openFDA PMA Record

Device: ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY SYSTEM
Applicant: Boston Scientific Corp
PMA number: P100023
Supplement: S008
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2011-07-27
Decision code: OK30
Date received: 2011-07-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ALTERNATE INHERENT VISCOSITY TEST METHOD FOR TESTING OF AESON-BLENDED RESIN AND ANNEALED GRADIENT OUTER TUBING COMPONENT, AND AN UPDATE OF ASSOCIATED SPECIFICATIONS.