TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA premarket approval P030025/S044 · decided 2009-05-15
Approval details
- PMA number
- P030025
- Supplement
- S044
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Boston Scientific Corp
- Date received
- 2007-02-13
- Decision date
- 2009-05-15
- Days to decision
- 822 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL TO UPDATE THE INFORMATION IN THE INSTRUCTIONS FOR USE RELATED TO MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY.
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