TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA premarket approval P030025/S049 · decided 2008-12-04
Approval details
- PMA number
- P030025
- Supplement
- S049
- 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
- 2007-08-23
- Decision date
- 2008-12-04
- Days to decision
- 469 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR A CHANGE IN THE SAMPLING PERFORMED BY THE SUPPLIER FOR MEASURING THE COATING THICKNESS OF THE HYPOTUBE COMPONENT.
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