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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 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)
Classification Namestimulator, ultrasound and muscle, for use other than applying therapeutic deep
Generic Namelow-intensity pulsed ultrasonic device for the treatment on nonunion
ApplicantSMITH & NEPHEW, INC.
PMA NumberP900009
Supplement NumberS028
Date Received07/20/2007
Decision Date08/16/2007
Product Code
LPQ[ Registered Establishments with LPQ ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the manufacture of the exogen 4000+ device to a continuous flow manufacturing model and a change in the serial numbering scheme of the device.
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