PMA P060008S035
- Device
- TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P060008
- Supplement
- S035
- Product code
- NIQ
- Decision date
- 2010-06-11
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL FOR A CHANGE FROM A MANUAL TO AN AUTOMATED COATING PROCESS.
Current openFDA PMA Record
- Device
- TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P060008
- Supplement
- S035
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2010-06-11
- Decision code
- APPR
- Date received
- 2009-12-24
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE FROM A MANUAL TO AN AUTOMATED COATING PROCESS.