PMA P060008S047

Device: TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Applicant: Boston Scientific Corp
PMA number: P060008
Supplement: S047
Product code: NIQ
Decision date: 2010-05-17
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL FOR MR COMPATIBILITY LABELING CHANGES TO THE DIRECTIONS FOR USE (DFU) AND PATIENT INFORMATION GUIDE (PG) FOR THE TAXUS LIBERTÉ MONORAIL (MR) AND OVER-THE-WIRE (OTW) STENT DELIVERY SYSTEMS.

Current openFDA PMA Record

Device: TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Applicant: Boston Scientific Corp
PMA number: P060008
Supplement: S047
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2010-05-17
Decision code: APPR
Date received: 2010-03-19
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR MR COMPATIBILITY LABELING CHANGES TO THE DIRECTIONS FOR USE (DFU) AND PATIENT INFORMATION GUIDE (PG) FOR THE TAXUS LIBERTÉ MONORAIL (MR) AND OVER-THE-WIRE (OTW) STENT DELIVERY SYSTEMS.