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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 NameORACLE(TM) CORONARY BALLOON DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter with ultrasound
Regulation Number870.5100
ApplicantABBOTT VASCULAR DEVICES
PMA NumberP910031
Date Received06/07/1991
Decision Date09/30/1994
Reclassified Date 10/08/2011
Product Code
LOX[ Registered Establishments with LOX ]
Docket Number 94M-0402
Notice Date 12/15/1994
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S015 S016 S017 S019 S021 S022 
S023 S024 S026 
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