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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 2000
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 NumberS006
Date Received07/02/1998
Decision Date02/22/2000
Product Code
LPQ[ Registered Establishments with LPQ ]
Docket Number 00M-0810
Advisory Committee General & Plastic Surgery
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Approval Order
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