TAXUS EXPRESS2 PACLITAXEL CORONARY STENT SYSTEM
FDA premarket approval P030025/S021 · decided 2008-09-24
Approval details
- PMA number
- P030025
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TAXUS EXPRESS2 PACLITAXEL CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Boston Scientific Corp
- Date received
- 2005-08-02
- Decision date
- 2008-09-24
- Days to decision
- 1149 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR STENT DIAMETERS WHICH EXPAND THE PRODUCT MATRIX TO INCLUDE 2.25 MM AND 4.0MM TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEMS. THE DEVICE, ASMODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TAXUS EXPRESS2 PACLITAXEL-ELUTINGCORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW) AND IS INDICATED FOR THEFOLLOWING: THE TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM IS INDICATED FOR IMPROVINGLUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTE
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