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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMODULARIS LITHO
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Nameextracorporeal shock wave ltthrtripsy (eswl)
Regulation Number876.5990
ApplicantSIEMENS MEDICAL SOLUTIONS USA, INC.
PMA NumberP870018
Supplement NumberS021
Date Received05/01/1998
Decision Date09/21/1998
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a compact transportable (within the hospital only) configuration of the lithostar(r) shock wave system c. The device, as modified, will be marketed under the trade name lithostar(r) modularis and is indicated for use in the fragmentation of urinary tract stones, i. E. , renal calyceal stones, renal pelvic stones, and upper ureteral stones.
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