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

FDA premarket approval P100023/S015 · decided 2012-02-22

Approval details

PMA number

P100023

Supplement

S015

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

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

Generic name

Coronary drug-eluting stent

Applicant

Boston Scientific Corp

Date received

2011-07-15

Decision date

2012-02-22

Days to decision

222 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 ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE). THE ION STENT SYSTEM IS INDICATED FOR IMPROVING LUMINAL DIAMETER: 1) FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES 2.25 MM TO 4.00 MM IN DIAMETER IN LESIONS <= 34 MM IN LENGTH; OR 2) IN PATIENTS UNDERGOING PRIMARY ANGIOPLASTY TO TREAT ACUTE ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION, TRUE POSTERIOR MYOCARDIAL INFARCTION, OR PRESUMED NEW LEFT BUNDLE BRAN

510(k) clearances by this applicant