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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 NameLITHOSTAR
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Nameextracorporeal shock wave ltthrtripsy (eswl)
Regulation Number876.5990
ApplicantSIEMENS CORP.
PMA NumberP870018
Date Received04/28/1987
Decision Date09/30/1988
Reclassified Date 09/08/2000
Product Code
LNS[ Registered Establishments with LNS ]
Docket Number 88M-0363
Notice Date 11/30/1988
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S013 S014 S015 S016 S017 S019 S021 
S022 S023 S024 S025 
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