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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 NameTRIPTER-X1 NOVA
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Namelithotripter
Regulation Number876.5990
ApplicantMEDIREX, INC.
PMA NumberP920034
Date Received07/09/1992
Decision Date09/20/1996
Reclassified Date 09/08/2000
Product Code
LNS[ Registered Establishments with LNS ]
Docket Number 96M-0473
Notice Date 12/10/1996
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the tripter-x1 series extracorporeal shock wave lithotripters (tripter-x1, tripter-x1 nova, and tripter-x1 compact.
Supplements: S001 S002 S003 
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