PMA P030025S078
- Device
- Taxus Express2 Paclitaxel-eluting Coronary Stent S
- Applicant
- Boston Scientific Corp.
- PMA number
- P030025
- Supplement
- S078
- Decision date
- 2010-08-13
Current openFDA PMA Record
- Device
- TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEMS (MONORAIL & OVER-THE-WIRE)
- Applicant
- Boston Scientific Corp
- PMA number
- P030025
- Supplement
- S078
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2010-08-13
- Decision code
- APPR
- Date received
- 2009-11-10
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE TO THE LASER CUTTING SETUP PROCESS.