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TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA premarket approval P060008/S047 · decided 2010-05-17

Approval details

PMA number
P060008
Supplement
S047
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Generic name
Coronary drug-eluting stent
Applicant
Boston Scientific Corp
Date received
2010-03-19
Decision date
2010-05-17
Days to decision
59 days
Decision code
APPR
Product code
NIQ
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
APPROVAL FOR MR COMPATIBILITY LABELING CHANGES TO THE DIRECTIONS FOR USE (DFU) AND PATIENT INFORMATION GUIDE (PG) FOR THE TAXUS LIBERTÉ MONORAIL (MR) AND OVER-THE-WIRE (OTW) STENT DELIVERY SYSTEMS.

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510(k) clearances by this applicant

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