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TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)

FDA premarket approval P030025/S014 · decided 2005-02-15

Approval details

PMA number
P030025
Supplement
S014
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
Generic name
Coronary drug-eluting stent
Applicant
Boston Scientific Corp
Date received
2005-01-25
Decision date
2005-02-15
Days to decision
21 days
Decision code
APPR
Product code
NIQ
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
APPROVAL FOR LABELING CHANGES THAT STRENGTHEN THE INSTRUCTIONS REGARDING APPROPRIATE METHODS TO BE USED WHEN A PHYSICIAN EXPERIENCES WITHDRAWAL RESISTANCE FOLLOWING STENT DEPLOYMENT AND BALLOON DEFLATION.

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510(k) clearances by this applicant

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