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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceDORNIER EPOS ULTRA
Generic NameGenerator, shock-wave, for pain relief
ApplicantDornier Medtech America, Inc.
1155 Roberts Blvd.
Kennesaw, GA 30144
PMA NumberP000048
Date Received11/21/2000
Decision Date01/15/2002
Withdrawal Date08/15/2018
Product Code NBN 
Docket Number 02M-0034
Notice Date 01/25/2002
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE DORNIER EPOS ULTRA. THE DORNIER EPOS ULTRA IS A NON-SURGICAL ALTERNATIVE FOR THE TREATMENT OF CHRONIC PLANTAR FASCIITIS FOR PATIENTS WITH SYMPTOMS OF PLANTAR FASCIITIS FOR 6 MONTHS OR MORE AND A HISTORY OF UNSUCCESSFUL CONSERVATIVE THERAPY. PLANTAR FASCIITIS IS DEFINED AS THE TRACTION DEGENERATION OF THE PLANTAR FASCIAL BAND AT ITS ORIGIN ON THE MEDICAL TUBERCLE OF THE CALCANEUS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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