PMA P030025S093
- Device
- TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P030025
- Supplement
- S093
- Product code
- NIQ
- Decision date
- 2011-07-25
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO UPDATE THE DIRECTIONS FOR USE TO INCLUDE ADDITIONAL DATA FROM THE TAXUS VISR STUDY.
Current openFDA PMA Record
- Device
- TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P030025
- Supplement
- S093
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2011-07-25
- Decision code
- APPR
- Date received
- 2011-04-19
- Supplement type
- Normal 180 Day Track No User Fee
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO UPDATE THE DIRECTIONS FOR USE TO INCLUDE ADDITIONAL DATA FROM THE TAXUS VISR STUDY.