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 the healthtronics ossatron. The device is indicated for use for performing extracorporeal shock wave (esw) treatment in patients with chronic lateral epicondylitis (tennis elbow) that has failed to respond to conservative treatment. Chronic lateral epicondylitis is defined as lateral epicondylitis that has persisted for 6 months or more with a history of unsuccessful conservative treatment.
| Device | HEALTHTRONICS OSSATRON |
| Classification Name | Generator, Shock-wave, For Pain Relief |
| Generic Name | Generator, Shock-wave, For Pain Relief |
| Applicant | SANUWAVE, INC. |
| Date Received | 2001-11-05 |
| Decision Date | 2003-03-14 |
| Notice Date | 2003-05-01 |
| PMA | P990086 |
| Supplement | S003 |
| Product Code | NBN |
| Docket Number | 03M-0173 |
| Advisory Committee | Physical Medicine |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 Labeling Part 2 |
| 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 |