HEALTHTRONICS OSSATRON
FDA premarket approval P990086/S003 · decided 2003-03-14
Approval details
- PMA number
- P990086
- Supplement
- S003
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HEALTHTRONICS OSSATRON
- Generic name
- Generator, shock-wave, for pain relief
- Applicant
- Sanuwave, Inc.
- Date received
- 2001-11-05
- Decision date
- 2003-03-14
- Days to decision
- 494 days
- Decision code
- APPR
- Product code
- NBN
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Alpharetta, GA
- 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.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| dermaPACE System (DEN160037) | Sanuwave, Inc. | 2017-12-28 |