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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.
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter with ultrasound
Regulation Number870.5100
PMA NumberP910031
Supplement NumberS003
Date Received06/02/1995
Decision Date12/07/1995
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 endosonics oracle focus ptca catheter, as modified will be marketed under the trade name endosonics oracle focus ptca catheter.