|
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 |
Supplement Number | S003 |
Date Received | 11/05/2001 |
Decision Date | 03/14/2003 |
Withdrawal Date
|
02/08/2021 |
Product Code |
NBN |
Docket Number | 03M-0173 |
Notice Date | 05/01/2003 |
Advisory Committee |
Physical Medicine |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |