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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 (SAFHS) MODEL 2000, EXOGEN 2000
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 NumberS009
Date Received04/03/2000
Decision Date06/22/2000
Product Code
LPQ[ Registered Establishments with LPQ ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the manufacturing facility at smith & nephew, inc. , orthopaedic division, memphis, tennessee 38116.
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