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.
This device is indicated for use for performing extracorporeal shock wave treatment in patients with chronic proximal plantar fasciitis that has failed to respond to conservative treatment. Chronic proximal plantar fasciitis is defined as pain in the area of the insertion of the plantar fascia on the medial calcaneal tuberosity that has persisted for six months or more.
| Device | HEALTHTRONICS OSSATRON |
| Classification Name | Generator, Shock-wave, For Pain Relief |
| Generic Name | Generator, Shock-wave, For Pain Relief |
| Applicant | SANUWAVE, INC. |
| Date Received | 1999-12-30 |
| Decision Date | 2000-10-12 |
| Notice Date | 2001-06-18 |
| PMA | P990086 |
| Supplement | S |
| Product Code | NBN |
| Docket Number | 01M-0271 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SANUWAVE, INC. 11680 Great Oaks Way suite 350 alpharetta, GA 30022 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990086 | Original Filing | |
| S004 | 2004-02-09 | Normal 180 Day Track No User Fee |
| S003 | 2001-11-05 | Panel Track |
| S002 | 2001-01-12 | Real-time Process |
| S001 | 2000-10-19 | Normal 180 Day Track |