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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 NameSONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
Classification Namestimulator, ultrasound and muscle, for use other than applying therapeutic deep
Generic Namebone growth stimulator
ApplicantEXOGEN
PMA NumberP900009
Supplement NumberS001
Date Received02/14/1995
Decision Date07/07/1995
Product Code
LPQ[ Registered Establishments with LPQ ]
Advisory Committee Physical Medicine
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for supplementary references for physician installation and patient use of the safhs model 2a device.
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