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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTHERASONIC LITHOTRIPSY TREATMENT SYSTEM
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Namelithotriptor, extracorporeal shock-wave,urological
Regulation Number876.5990
Applicant
FOCUS SURGERY, INC.
1565 barber ln.
milpitas, CA 95035
PMA NumberP890066
Date Received12/07/1989
Decision Date12/20/1991
Withdrawal Date 05/25/1995
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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