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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.
 
DeviceSIEMENS SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT) SYSTEM
Generic NameGenerator, shock-wave, for pain relief
ApplicantSiemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Mavern, PA 19355
PMA NumberP010039
Supplement NumberS002
Date Received11/13/2002
Decision Date04/03/2003
Withdrawal Date08/05/2016
Product Code NBN 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE. THE POST-APPROVAL STUDY HAS BEEN SUBMITTED TO COMPLY WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE JULY, 19, 2002 APPROVAL ORDER FOR P010039.
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