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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceORBASONE PAIN RELIEF SYSTEM
Generic NameGenerator, shock-wave, for pain relief
ApplicantORTHOMETRIX, INC.
5621 STRAND BLVD
SUITE 111
NAPLES, FL 34110
PMA NumberP040039
Date Received09/14/2004
Decision Date08/10/2005
Withdrawal Date 12/19/2011
Product Code NBN 
Docket Number 05M-0339
Notice Date 08/25/2005
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ORBASONE PAIN RELIEF SYSTEM. THE DEVICE IS INDICATED FOR EXTRACORPOREAL SHOCK WAVE THERAPY FOR THE TREATMENT OF CHRONIC PROXIMAL PLANTAR FASCIITIS IN PATIENTS 18 YEARS OF AGE OR OLDER THAT HAVE FAILED TO RESPOND TO CONSERVATIVE THERAPY. CHRONIC PROXIMAL PLANTAR FASCIITIS IS DEFINED AS HEEL PAIN IN THE AREA OF THE INSERTION OF THE PLANTAR FASCIA ON THE MEDIAL CALCANEAL TUBEROSITY THAT HAS PERSISTED FOR SIX MONTHS OR MORE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  
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