TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA premarket approval P030025/S059 · decided 2009-03-20
Approval details
- PMA number
- P030025
- Supplement
- S059
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Boston Scientific Corp
- Date received
- 2008-09-29
- Decision date
- 2009-03-20
- Days to decision
- 172 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR CHANGES TO THE SIZE OF THE SIBS PIECES AND THE PROCESS FOR MIXING AND FILTERING THE SPRAY COATING SOLUTION USED TO MANUFACTURE THE DEVICE.
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