PMA P990086S003
- Device
- HEALTHTRONICS OSSATRON
- Applicant
- Sanuwave, Inc.
- PMA number
- P990086
- Supplement
- S003
- Product code
- NBN
- Decision date
- 2003-03-14
- Classification
- Generator, Shock-wave, For Pain Relief
- Generic name
- Generator, shock-wave, for pain relief
- 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.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P990086S003B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- HEALTHTRONICS OSSATRON
- Applicant
- Sanuwave, Inc.
- PMA number
- P990086
- Supplement
- S003
- Product code
- NBN
- Generic name
- Generator, shock-wave, for pain relief
- Decision date
- 2003-03-14
- Decision code
- APPR
- Date received
- 2001-11-05
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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.