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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.
 
Trade NameEXOGEN 3000
Classification Namestimulator, ultrasound and muscle, for use other than applying therapeutic deep
Generic Namelow-intensity pulsed ultrasonic device for the treatment on nonunion
ApplicantEXOGEN
PMA NumberP900009
Supplement NumberS008
Date Received10/27/1999
Decision Date04/14/2000
Product Code
LPQ[ Registered Establishments with LPQ ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for various design and manufacturing changes which do not affect the output of the device. The device, as modified, will be marketed under the trade name exogen 3000.
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