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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 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM
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 NumberS012
Date Received10/12/2000
Decision Date02/21/2001
Product Code
LPQ
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in labeling for the exogen 3000(r), to incorporate both the fresh fracture and nonunion information into one set of physician's instructions for use, patient's instructions for use, and product insert bulletin; to make manual size and formatting changes, and to add nonunion background information.
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