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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 NameTHE ORACLE MEGASONICS FIVE-64 PTCA CATHER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter with ultrasound
Regulation Number870.5100
ApplicantCARDIOVASCULAR DYNAMICS, INC.
PMA NumberP910031
Supplement NumberS019
Date Received06/15/1998
Decision Date12/11/1998
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the endosonics oracle megasonics five-64(tm) ptca catheter.
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