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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.
Classification Namestimulator, ultrasound and muscle, for use other than applying therapeutic deep
Generic Namestimulator, ultrasound and muscle, for use other than applying therapeutic deep
4721 emperor blvd suite 100
durham, NC 27703
PMA NumberP900009
Supplement NumberS007
Date Received07/07/1999
Decision Date08/25/1999
Product Code
LPQ[ Registered Establishments with LPQ ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a name change from SAFHS 2000(R) to Exogen 2000(R). The device is indicated for the acceleration of the time to a healed fracture for fresh*, closed, posteriorly displaced distal radius (Colles') fractures, and fresh*, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopedically managed by closed reduction and cast immobilization. *All fractures in both clinical studies were treated with SAFHS(R) therapy within seven days for fracture.