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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 2000+(TM) SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R))
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 NumberS013
Date Received04/30/2001
Decision Date09/04/2001
Product Code
LPQ[ Registered Establishments with LPQ ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the low intensity ultrasound fracture treatment system-sonic accelerated fracture healing system (safhs(r)). The device, as modified, will be marketed under the trade name exogen 2000+(tm) sonic accelerated fracture healing system (safhs(r)) and is indicated for the non-invasive treatment of estblished nonunions* exluding skull and vertebra. In addition, the exogen 2000+(tm) or sonic accelerated fracture healing system (safhs(r)) is indicated for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or grade 1 open tibial diaphysis in skeletally mature individuals when these fractures are orthopedically managed by closed reduction and cast immobilization. * a nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.
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