PMA P060008S075
- Device
- TAXUS LIBERTE OTW PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P060008
- Supplement
- S075
- Product code
- NIQ
- Decision date
- 2011-09-27
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- CHANGES TO PROCESS METHODS AND SOFTWARE SUPPORTING THE PLASMA TREATER AND THE HYDROPHILIC COATING (HPC) EQUIPMENT.
Current openFDA PMA Record
- Device
- TAXUS LIBERTE OTW PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P060008
- Supplement
- S075
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2011-09-27
- Decision code
- OK30
- Date received
- 2011-08-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO PROCESS METHODS AND SOFTWARE SUPPORTING THE PLASMA TREATER AND THE HYDROPHILIC COATING (HPC) EQUIPMENT.