PMA P030025S079
- Device
- Taxus Express2 Paclitaxel-eluting Coronary Stent
- Applicant
- Boston Scientific Corp.
- PMA number
- P030025
- Supplement
- S079
- Decision date
- 2009-12-17
Current openFDA PMA Record
- Device
- TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT
- Applicant
- Boston Scientific Corp
- PMA number
- P030025
- Supplement
- S079
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2009-12-17
- Decision code
- OK30
- Date received
- 2009-12-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REDUCTION IN THE ACID WASHING CHANGE OUT FREQUENCY.