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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceSIEMENS SONOCUR BASIC SYSTEM
Classification Namegenerator, shock-wave, for pain relief
Generic Namegenerator, shock-wave, for pain relief
Applicant
SIEMENS 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[ Registered Establishments with NBN ]
Docket Number 01M-0336
Notice Date 08/06/2002
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002 S003 
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