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.
| Device | EMS SWISS DOLORCLAST |
| Generic Name | Generator, Shock-wave, For Pain Relief |
| Applicant | ELECTRO MEDICAL SYSTEMS (EMS SA) |
| Date Received | 2005-02-02 |
| Decision Date | 2007-05-08 |
| Notice Date | 2007-06-28 |
| PMA | P050004 |
| Supplement | S |
| Product Code | NBN |
| Docket Number | 07M-0253 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ELECTRO MEDICAL SYSTEMS (EMS SA) ch. De La Vuarpilliere 31 nyon, Vaud CH-12-1260 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P050004 | | Original Filing |
| S001 |
2009-02-25 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices