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Device | ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE |
Generic Name | Generator, shock-wave, for pain relief |
Applicant | MEDISPEC, LTD. 203 PERRY PARKWAY Suite 6 GAITHERSBURG, MD 20877 |
PMA Number | P040026 |
Date Received | 06/04/2004 |
Decision Date | 04/01/2005 |
Product Code |
NBN |
Docket Number | 05M-0241 |
Notice Date | 06/20/2005 |
Advisory Committee |
Physical Medicine |
Expedited Review Granted? | No |
Combination Product | No |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Supplements: |
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