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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 NameTHERASONIC LITHOTRIPSY TREATMENT SYSTEM
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Namelithotripter system
Regulation Number876.5990
ApplicantFOCUS SURGERY, INC.
PMA NumberP890066
Date Received12/07/1989
Decision Date12/20/1991
Reclassified Date 09/08/2000
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S003 S004 S005 
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