PMA P030025S069
- Device
- Taxus Express Paclitaxel-eluting Coronary Stent Sy
- Applicant
- Boston Scientific Corp.
- PMA number
- P030025
- Supplement
- S069
- Decision date
- 2010-04-27
Current openFDA PMA Record
- Device
- TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P030025
- Supplement
- S069
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2010-04-27
- Decision code
- APPR
- Date received
- 2009-11-05
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE IN THE STENT COATING PROCESS.