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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 NameTRIPTER-X1
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Namelithotripter
Regulation Number876.5990
ApplicantMEDIREX, INC.
PMA NumberP920034
Supplement NumberS003
Date Received11/12/1998
Decision Date12/14/1998
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
1)contained the final report of postapproval study regarding the possible relationship between extracorporeal shock wave lithotripsy and the onset of hypertension, and 2) requested approval for modifications to the tripter-x1's labeling to reflect the results of this final report.
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