PMA P060008S057
- Device
- Taxus Liberte Paclitaxel-eluting Coronary Stent Sy
- Applicant
- Boston Scientific Corp.
- PMA number
- P060008
- Supplement
- S057
- Decision date
- 2011-03-01
Current openFDA PMA Record
- Device
- TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P060008
- Supplement
- S057
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2011-03-01
- Decision code
- APPR
- Date received
- 2010-07-07
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR UPDATING THE PATIENT GUIDE INTO TWO SEPARATE DOCUMENTS (ANGIOPLASTY AND STENT EDUCATION GUIDE AND PATIENT INFORMATION GUIDE).