| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | EMS SWISS DOLORCLAST |
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| Generic Name | Generator, shock-wave, for pain relief |
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| Applicant | ELECTRO MEDICAL SYSTEMS (EMS SA)
CH. DE LA VUARPILLIERE 31
NYON, VAUD CH-12-1260 |
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| PMA Number | P050004 |
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| Date Received | 02/02/2005 |
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| Decision Date | 05/08/2007 |
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| Product Code |
NBN |
| Docket Number | 07M-0253 |
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| Notice Date | 06/28/2007 |
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| Advisory Committee |
Orthopedic |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
APPROAL FOR THE EMS SWISS DOLORCLAST. THE EMS SWISS DOLORCLAST IS A NON-SURGICAL ALTERNATIVE INDICATED FOR THE TREATMENT OF CHRONIC PROXIMAL PLANTAR FASCIITIS FOR PATIENTS 18 YEARS OF AGE OR OLDER WITH SYMPTOMS FOR 6 MONTHS OR MORE AND A HISTORY OF UNSUCCESSFUL CONSERVATIVE THERAPY. CHRONIC PROXIMAL PLANTAR FASCIITIS IS DEFINED AS HEEL PAIN IN THE AREA OF THE INSERTION OF THE PLANTAR FASCIA ON THE MEDICAL CALCANEAL TUBEROSITY. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S001 |
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