| Note: 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. |
| |
| Device | HEALTHTRONICS OSSATRON |
|---|
| Generic Name | Generator, shock-wave, for pain relief |
|---|
| Applicant | SANUWAVE, INC.
11680 GREAT OAKS WAY
SUITE 350
ALPHARETTA, GA 30022 |
|---|
| PMA Number | P990086 |
|---|
| Date Received | 12/30/1999 |
|---|
| Decision Date | 10/12/2000 |
|---|
|
Withdrawal Date
|
02/08/2021 |
|---|
| Product Code |
NBN |
| Docket Number | 01M-0271 |
|---|
| Notice Date | 06/18/2001 |
|---|
| Advisory Committee |
Orthopedic |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
Approval Order Statement
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. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
|---|
| Labeling | Labeling
|
|---|
| Supplements: |
S001 S002 S003 S004 |
|
|
