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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameGENESTONE 190 LITHOTRIPTER
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Nameextracorporeal shock wave lithotripter
Regulation Number876.5990
ApplicantBMT, INC.
PMA NumberP970062
Date Received12/23/1997
Decision Date06/24/1998
Reclassified Date 09/08/2000
Product Code
LNS[ Registered Establishments with LNS ]
Docket Number 98M-0507
Notice Date 10/07/1998
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the genestone 190 lithotripter. This device is indicated for use in the non-invasive fragmentation of kidney (renal pelvic and renal calyceal) and upper ureteral stones between 5 and 20mm in size.
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