PMA P060008S013
- Device
- Taxus Liberte Paclitaxel-eluting Coronary Stent Sy
- Applicant
- Boston Scientific Corp.
- PMA number
- P060008
- Supplement
- S013
- Decision date
- 2010-06-28
Current openFDA PMA Record
- Device
- TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)
- Applicant
- Boston Scientific Corp
- PMA number
- P060008
- Supplement
- S013
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2010-06-28
- Decision code
- APPR
- Date received
- 2009-03-06
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.