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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDORNIER LITHOTRIPTER (STATIONARY AND MOBILE)
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantDornier MedTech America, Inc.
1155 ROBERTS BLVD.
KENNESAW, GA 30144
PMA NumberP840008
Supplement NumberS063
Date Received05/18/1998
Decision Date06/19/1998
Reclassified Date 09/08/2000
Product Code LNS 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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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