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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.
 
DeviceEDAP LT.01 SHOCK WAVE LITHOTRIPTER
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantEdap International Corp.
179 Sidney St.
Cambridge, MA 02139
PMA NumberP880042
Supplement NumberS001
Date Received02/14/1994
Decision Date04/18/1994
Withdrawal Date02/19/1997
Product Code LNS 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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