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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.
Classification Namegenerator, shock-wave, for pain relief
Generic Nameorthopedic extracorporeal shock wave system
PMA NumberP990086
Supplement NumberS003
Date Received11/05/2001
Decision Date03/14/2003
Product Code
NBN[ Registered Establishments with NBN ]
Docket Number 03M-0173
Notice Date 05/01/2003
Advisory Committee General & Plastic Surgery
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the healthtronics ossatron. The device is indicated for use for performing extracorporeal shock wave (esw) treatment in patients with chronic lateral epicondylitis (tennis elbow) that has failed to respond to conservative treatment. Chronic lateral epicondylitis is defined as lateral epicondylitis that has persisted for 6 months or more with a history of unsuccessful conservative treatment.
Approval Order Approval Order