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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE
Generic NameGenerator, shock-wave, for pain relief
ApplicantMEDISPEC, LTD.
203 PERRY PARKWAY
Suite 6
GAITHERSBURG, MD 20877
PMA NumberP040026
Date Received06/04/2004
Decision Date04/01/2005
Product Code NBN 
Docket Number 05M-0241
Notice Date 06/20/2005
Advisory Committee Physical Medicine
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE. THE DEVICE IS INDICATED FOR THE TREATMENT OF PROXIMAL PLANTAR FASCIITIS WITH OR WITHOUT HEEL SPUR IN PATIENTS 18 YEARS OF AGE OR OLDER. THE ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY IS A NON-INVASIVE ALTERNATIVE METHOD FOR PATIENT WITH SYMPTOMS OF PROXIMAL PLANTAR FASCIITIS FOR 6 MONTHS OR MORE AND A HISTORY OF UNSUCCESSFUL CONSERVATIVE THERAPIES TO RELIEVE HEEL PAIN. PROXIMAL PLANTAR FASCIITIS IS DEFINED AS HEEL PAIN IN THE AREA OF THE INSERTION OF THE PLANTAR FASCIA ON THE PLANTAR CALCANEAL TUBEROSITY.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  
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