This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for certain ergonomic and safety design changes and a device performance change, i. E. , providing the option of using 4 hz frequency of the shock wave delivery, as well as labeling changes in the operator manual to provide adequate instructions and information about these changes. The device, as modified, will be marketed under the trade name healthtronics ossatron(r) and is indicated for use for performing extracorporeal shock wave (esw) treatment in patients with chronic proximal plantar fasciitis that have failed to respond to conservative treatment. Chronic proximal plantar fasciitis is defined as pain in the area of 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 | 2001-01-12 |
| Decision Date | 2001-03-30 |
| PMA | P990086 |
| Supplement | S002 |
| Product Code | NBN |
| Advisory Committee | Physical Medicine |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SANUWAVE, INC. 11680 Great Oaks Way suite 350 alpharetta, GA 30022 |
| 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 |