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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.
 
DeviceTRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantMedirex, Inc.
49 Walnut Park
Wellesley Hills, MA 02181
PMA NumberP920034
Supplement NumberS001
Date Received03/18/1997
Decision Date03/26/1997
Reclassified Date09/08/2000
Product Code LNS 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES DESCRIBING THE TRANSPORTABILITY OF THE DEVICE
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