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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 NumberS025
Date Received02/22/2007
Decision Date06/11/2007
Product Code
LPQ[ Registered Establishments with LPQ ]
Advisory Committee General & Plastic Surgery
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional supplier of the external plastic housing for the main operating unit. This includes the top housing, the bottom housing, the push button and the lens.
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