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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.
Classification Namegenerator, shock-wave, for pain relief
Generic Namegenerator, shock-wave, for pain relief
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