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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 NameHEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Nameextracorporeal shock wave lithotripter
Regulation Number876.5990
ApplicantHEALTH TRONICS SURGICAL SERVICES, INC.
PMA NumberP970019
Date Received05/16/1997
Decision Date07/21/1997
Reclassified Date 09/08/2000
Product Code
LNS[ Registered Establishments with LNS ]
Docket Number 97M-0453
Notice Date 11/14/1997
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the lithotron(tm) lithotripsy system. This device is indicated for use in patients with renal and upper ureteral calculi between 4 and 20 mm in size.
Supplements: S001 S002 S003 S004 S005 S006 
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