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

FDA premarket approval P060008/S046 · decided 2012-02-22

Approval details

PMA number

P060008

Supplement

S046

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

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

Generic name

Coronary drug-eluting stent

Applicant

Boston Scientific Corp

Date received

2010-03-08

Decision date

2012-02-22

Days to decision

716 days

Decision code

APPR

Product code

NIQ

Advisory committee

Cardiovascular

Expedited review

No

Location

Maple Grove, MN

Statement

APPROVAL TO EXPAND THE LABELED INDICATIONS FOR THE TAXUS LIBERTÈ PACLITAXEL-ELUTING CORONARY STENT SYSTEM. THE TAXUS® LIBERTÈ® PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS) IS INDICATED FOR IMPROVING LUMINAL DIAMETER: 1) FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES 2.75 MM TO 4.00 MM IN DIAMETER IN LESIONS <= 34 MM IN LENGTH; 2) FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES 2.25 MM TO 2.50 MM IN DIAMETER IN LESIONS <= 28 MM I

510(k) clearances by this applicant