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Device | ORBASONE PAIN RELIEF SYSTEM |
Generic Name | Generator, shock-wave, for pain relief |
Applicant | ORTHOMETRIX, INC. 5621 STRAND BLVD SUITE 111 NAPLES, FL 34110 |
PMA Number | P040039 |
Date Received | 09/14/2004 |
Decision Date | 08/10/2005 |
Withdrawal Date
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12/19/2011 |
Product Code |
NBN |
Docket Number | 05M-0339 |
Notice Date | 08/25/2005 |
Advisory Committee |
Orthopedic |
Expedited Review Granted? | No |
Combination Product | No |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
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