PMA P030025S062
- Device
- Taxus Express2 Paclitaxel-eluting Coronary Stent S
- Applicant
- Boston Scientific Corp.
- PMA number
- P030025
- Supplement
- S062
- Decision date
- 2012-05-04
Current openFDA PMA Record
- Device
- TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P030025
- Supplement
- S062
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2012-05-04
- Decision code
- APPR
- Date received
- 2008-12-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR REVISIONS TO THE DIRECTIONS FOR USE (DFU) TO INCORPORATED THE LATEST AVAILABLE CLINICAL FOLLOW-UP DATA.