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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 NameDORNIER LITHOTRIPTER (STATIONARY AND MOBILE)
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Nameextracorporeal shock-wave lithotripter
Regulation Number876.5990
ApplicantDORNIER MEDTECH AMERICA, INC.
PMA NumberP840008
Supplement NumberS063
Date Received05/18/1998
Decision Date06/19/1998
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revision of labeling regarding: 1) the risk of hypertension folloiwng renal lithotripsy, consistent with the conclusions of final postapproval study report (all models) 2) the maximum patient weight to be treated (hm4); and 3) additional safe treatment practices regarding non-ecg gated treatment (mfl 5000).
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