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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 NameTECHNOMED INTERNATIONAL SONOLITH 2000
Classification Namelithotriptor, extracorporeal shock-wave,urological
Regulation Number876.5990
ApplicantEDAP INTERNATIONAL CORP.
PMA NumberP880011
Date Received02/18/1988
Decision Date06/23/1989
Reclassified Date 09/08/2000
Product Code
LNS[ Registered Establishments with LNS ]
Docket Number 89M-0211
Notice Date 07/19/1989
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S007 S008 
S009 
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