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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.
 
DeviceECONOLITH(TM) LITHOTRIPTER
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantMedispec, Ltd.
19110 Montgomery Village Ave.
Suite 100
Montgomery Village, MD 20886
PMA NumberP950043
Supplement NumberS005
Date Received07/20/1998
Decision Date09/14/1998
Reclassified Date09/08/2000
Product Code LNS 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for relocation of manufacturing facility from Medispec, Ltd., 28 Hacharoshet T., Or-Yehuda, Israel to Medispec, Ltd., 24 Hatasiya St., Yahud, Or-Yehuda, Israel.
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