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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSIEMENS SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT) SYSTEM
Classification Namegenerator, shock-wave, for pain relief
Generic Nameextracorporeal shock wave therapy (eswt) system
ApplicantSIEMENS MEDICAL SOLUTIONS USA, INC.
PMA NumberP010039
Supplement NumberS002
Date Received11/13/2002
Decision Date04/03/2003
Product Code
NBN[ Registered Establishments with NBN ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement ode/oir
Expedited Review Granted? No
Combination Product No
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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