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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 NameORACLE(TM) CORONARY BALLOON DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter with ultrasound
Regulation Number870.5100
ApplicantENDOSONICS CORP.
PMA NumberP910031
Supplement NumberS005
Date Received09/07/1995
Decision Date03/13/1996
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the arc coronary balloon dilatation catheter.
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