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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 NumberS001
Date Received10/19/2000
Decision Date05/01/2001
Withdrawal Date 02/08/2021
Product Code NBN 
Advisory Committee Physical Medicine
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE POST MARKET APPROVAL STUDY PROTOCOL.
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