PMA P060008S108
- Device
- Taxus Liberte Paclitaxel-eluting Coronary Stent Sy
- Applicant
- Boston Scientific Corp.
- PMA number
- P060008
- Supplement
- S108
- Decision date
- 2014-02-13
Current openFDA PMA Record
- Device
- TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P060008
- Supplement
- S108
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2014-02-13
- Decision code
- OK30
- Date received
- 2014-01-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- EQUIPMENT CHANGE TO ONE OF THE ETHYLENE OXIDE STERILIZATION CHAMBERS.