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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 NumberS004
Date Received02/09/2004
Decision Date08/06/2004
Withdrawal Date02/08/2021
Product Code NBN 
Advisory Committee Physical Medicine
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR INSERTION OF A TABLE OF ADVERSE EVENTS AND A BRIEF PARAGRAPH FOLLOWING THE POST-APPROVAL STUDY OF ESW TREATMENT OF PLANTAR FASCIITIS CONSTITUTING THE LABELING CHANGES IN THE OPERATING MANUAL.
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