Approval for the storz medical duolith sd1 shock wave therapy. This device is indicated for extracorporeal shock wave treatment of heel pain due to chronic proximal plantar fasciitis for patients of age greater than 18 years with a history of failed alternative conservative therapies for at least six months. Chronic proximal plantar fasciitis is defined as traction degeneration of the plantar fascial band at the origin on the medial calcaneal tuberosity that has persisted for six months or more.
| Device | STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY |
| Classification Name | Generator, Shock-wave, For Pain Relief |
| Generic Name | Generator, Shock-wave, For Pain Relief |
| Applicant | STORZ MEDICAL AG |
| Date Received | 2008-11-26 |
| Decision Date | 2016-01-08 |
| Notice Date | 2016-01-11 |
| PMA | P080028 |
| Supplement | S |
| Product Code | NBN |
| Docket Number | 16M-0122 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | STORZ MEDICAL AG lohstampfestrasse 8 tagerwilen CH-82-8274 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P080028 | | Original Filing |
| S001 |
2018-12-26 |
Normal 180 Day Track |
NIH GUDID Devices