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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHEALTHTRONICS OSSATRON
Generic NameGenerator, shock-wave, for pain relief
ApplicantSANUWAVE, INC.
11680 GREAT OAKS WAY
SUITE 350
ALPHARETTA, GA 30022
PMA NumberP990086
Supplement NumberS003
Date Received11/05/2001
Decision Date03/14/2003
Withdrawal Date 02/08/2021
Product Code NBN 
Docket Number 03M-0173
Notice Date 05/01/2003
Advisory Committee Physical Medicine
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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