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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTECHNOMED INTERNATIONAL SONOLITH 3000 (LITHORAY)TM
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantEDAP INTERNATIONAL CORP.
TWO BURLINGTON WOODS
BURLINGTON, MA 01803
PMA NumberP880011
Supplement NumberS007
Date Received11/01/1991
Decision Date02/10/1992
Reclassified Date 09/08/2000
Product Code LNS 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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