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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTRIPTER-X1 NOVA
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Namelithotriptor, extracorporeal shock-wave,urological
Regulation Number876.5990
Applicant
MEDIREX, INC.
49 walnut park
wellesley hills, MA 02181
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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