PMA P060008S067
- Device
- Taxus Liberte Paclitaxel-eluting Coronary Stent Sy
- Applicant
- Boston Scientific Corp.
- PMA number
- P060008
- Supplement
- S067
- Decision date
- 2011-08-12
Current openFDA PMA Record
- Device
- TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P060008
- Supplement
- S067
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2011-08-12
- Decision code
- APPR
- Date received
- 2011-02-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISED LABELING TO INCLUDE UPDATED CLINICAL TRIAL DATA THROUGH THE FINAL 5-YEAR TIME POINT FOR THE TAXUS ATLAS STUDY AND THROUGH THREE (3) YEARS FOR THE TAXUS ATLAS SMALL VESSEL AND LONG LESION STUDIES.