PMA P060008S053

Device: TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Applicant: Boston Scientific Corp
PMA number: P060008
Supplement: S053
Product code: NIQ
Decision date: 2010-12-01
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL FOR: 1) A CHANGE OF THE SUPPLIER OF TOLUENE; AND 2) A CHANGE TO THE INCOMING TOLUENE SPECIFICATIONS. THE DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS <= 28 MM IN LENGTH IN NATIVE CORONARY ARTERIES >= 2.5 MM TO <= 4.00 MM IN DIAMETER.

Current openFDA PMA Record

Device: TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Applicant: Boston Scientific Corp
PMA number: P060008
Supplement: S053
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2010-12-01
Decision code: APPR
Date received: 2010-05-19
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR: 1) A CHANGE OF THE SUPPLIER OF TOLUENE; AND 2) A CHANGE TO THE INCOMING TOLUENE SPECIFICATIONS. THE DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS = 2.5 MM TO