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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameFX MINIRAIL RX PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecoronary dilatation catheter
Regulation Number870.5100
ApplicantABBOTT VASCULAR INC.
PMA NumberP020037
Date Received09/10/2002
Decision Date06/11/2003
Reclassified Date 10/08/2010
Product Code
LOX[ Registered Establishments with LOX ]
Docket Number 03M-0320
Notice Date 06/30/2003
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the fx minirail tx percutaneous transluminal coronary angioplasty (ptca) catheter. The device is indicated for balloon dilatation of the stenotic portion of a coronary artery, including in-stent restenosis, for the purpose of improving myocardial perfusion.
Approval Order Approval Order
Supplements: S001 S002 
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