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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEXOGEN 2000+(TM) SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R))
Generic NameStimulator, ultrasound and muscle, for use other than applying therapeutic deep
ApplicantBIOVENTUS LLC
4721 EMPEROR BLVD SUITE 100
DURHAM, NC 27703
PMA NumberP900009
Supplement NumberS013
Date Received04/30/2001
Decision Date09/04/2001
Product Code LPQ 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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