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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
11 studebaker
irvine, CA 92618
PMA NumberP970052
Date Received11/04/1997
Decision Date02/20/1998
Withdrawal Date 03/30/2009
Product Code
LOX[ Registered Establishments with LOX ]
Docket Number 98M-0162
Notice Date 03/20/1998
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the FACT(TM), ARC(TM), LYNX(TM) and Guardian(TM) Balloon Coronary Dilatation Catheters. These devices are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purposed of improving myocardial perfusion. The application includes authorization from Endosoncis Corp., Rancho Cordova, CA, to incorporate information contained in its approved premarket approval application and related supplements for hte Cathscanner(R) Oracle(R) Micro PTCA Catheter.
Supplements: S001 S002