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 post market approval study protocol.
| Device | HEALTHTRONICS OSSATRON |
| Classification Name | Generator, Shock-wave, For Pain Relief |
| Generic Name | Generator, Shock-wave, For Pain Relief |
| Applicant | SANUWAVE, INC. |
| Date Received | 2000-10-19 |
| Decision Date | 2001-05-01 |
| PMA | P990086 |
| Supplement | S001 |
| Product Code | NBN |
| Advisory Committee | Physical Medicine |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| 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 |