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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.
 
DeviceSTORZ TRANSPORTABLE MODULITH SLX LITHOTRIPTER VERSION) ANSPORTABLE VERSION)
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantKARL STORZ ENDOSCOPY-AMERICA, INC.
1201 ROBERTS BLVD.
KENNESAW, GA 30144
PMA NumberP920051
Supplement NumberS006
Date Received03/26/1997
Decision Date03/27/1997
Reclassified Date 09/08/2000
Product Code LNS 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE OEC SERIES 9600 MOBILE IMAGING UNIT AND A PORTABLE COLLISION PROTECTOR TO BE USED WITH A TRANSPORTABLE VERSION OF YOUR SLX LITHOTRIPTER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TRANSPORTABLE MODULITH(R) SLX LITHOTRIPTER AND IS INDICATED FOR USE IN THE NONINVASIVE FRAGMENTATION OF URINARY CALCULI IN THE KIDNEY AND UPPER URETER.
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