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ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER

FDA premarket approval P980037 · decided 1999-03-12

Approval details

PMA number
P980037
Trade name
ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER
Generic name
CATHETER, CORONARY, ATHERECTOMY
Applicant
Boston Scientific Corp
Date received
1998-09-14
Decision date
1999-03-12
Days to decision
179 days
Decision code
APPR
Product code
MCX
Advisory committee
Cardiovascular
Expedited review
Yes
Location
Maple Grove, MN
Statement
Approval for the AngioJet(R) Rheolytic(TM) Thrombectomy system (AngioJet(R) Drive Unite, AngioJet(R) Pump Set, and AngioJet(R) Rheolytic(TM) Thrombectomy LF140 Catheter). This device is indicated for removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesion in vessels > 2.0mm in diameter prior to balloon angioplasty or stent placement.

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