PMA P030025S071
- Device
- TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P030025
- Supplement
- S071
- Product code
- NIQ
- Decision date
- 2009-12-02
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- MODIFICATION TO A STEP IN THE STENT FINAL INSPECTION WORK INSTRUCTION.
Current openFDA PMA Record
- Device
- TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P030025
- Supplement
- S071
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2009-12-02
- Decision code
- OK30
- Date received
- 2009-11-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION TO A STEP IN THE STENT FINAL INSPECTION WORK INSTRUCTION.