PMA P060008S054
- Device
- TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P060008
- Supplement
- S054
- Product code
- NIQ
- Decision date
- 2010-06-18
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- CHANGES TO THE DRUG ASSAY AND CONTENT UNIFORMITY METHOD, AND THE DRUG IMPURITIES AND DEGRADATION METHOD.
Current openFDA PMA Record
- Device
- TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P060008
- Supplement
- S054
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2010-06-18
- Decision code
- OK30
- Date received
- 2010-05-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE DRUG ASSAY AND CONTENT UNIFORMITY METHOD, AND THE DRUG IMPURITIES AND DEGRADATION METHOD.