TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA premarket approval P030025/S011 · decided 2004-11-11
Approval details
- PMA number
- P030025
- Supplement
- S011
- Supplement type
- 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
- 2004-11-02
- Decision date
- 2004-11-11
- Days to decision
- 9 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- CHANGE IN THE BACTERIAL ENDOTOXIN TEST USED AS PART OF THE FINISHED DEVICE TESTING.
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