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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCATHSCANNER ORACLE MICRO PTCA CATHETER FACT BALLOON CORONARY DILATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter with ultrasound
Regulation Number870.5100
ApplicantENDOSONICS CORP.
PMA NumberP910031
Supplement NumberS006
Date Received11/03/1995
Decision Date01/30/1996
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional manufacturing site:13900 alton parkway, suite 122, irvine, california, 92718 for the fact balloon coronary dilatation catheter.
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