PMA P030025S088
- Device
- Taxus Express2 Paclitaxel-eluting Coronary Stent S
- Applicant
- Boston Scientific Corp.
- PMA number
- P030025
- Supplement
- S088
- Decision date
- 2010-05-13
Current openFDA PMA Record
- Device
- TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P030025
- Supplement
- S088
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2010-05-13
- Decision code
- OK30
- Date received
- 2010-04-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REPLACEMENT OF THE FINAL INSPECTION CAMERA WITH ONE THAT PERFORMS THE EXISTING CATHETER FINAL INSPECTION PROCESS AT THE SDS FINAL INSPECTION STATION.