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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSIEMENS SONOCUR BASIC SYSTEM
Generic NameGenerator, shock-wave, for pain relief
ApplicantSIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MALVERN, PA 19355-1406
PMA NumberP010039
Date Received07/27/2001
Decision Date07/19/2002
Withdrawal Date 08/05/2016
Product Code NBN 
Docket Number 01M-0336
Notice Date 08/06/2002
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE SIEMENS SONOCUR BASIC. THE SIEMENS SONOCUR BASIC IS A NON-SURGICAL ALTERNATIVE FOR THE TREATMENT OF CHRONIC LATERAL EPICONDYLITIS (COMMONLY REFERRED TO AS TENNIS ELBOW) FOR PATIENTS WITH SYMPTOMS OF CHRONIC LATERAL EPICONDYLITIS FOR 6 MONTHS OR MORE AND A HISTORY OF UNSUCCESSFUL CONSERVATIVE TREATMENTS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S003 S002 
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