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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 NumberS002
Date Received12/15/1995
Decision Date04/02/1996
Product Code
LPQ[ Registered Establishments with LPQ ]
Advisory Committee Physical Medicine
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new manufacturing facility which is owned and operated by hi-tronics designs, inc. And located at 999 willow grove st. , building 2, suites 4a, 4b and 18e, hackettstown, nj 07840. The safhs model 2a will be manufactured at this site.
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