HEALTHTRONICS OSSATRON
FDA premarket approval P990086/S002 · decided 2001-03-30
Approval details
- PMA number
- P990086
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HEALTHTRONICS OSSATRON
- Generic name
- Generator, shock-wave, for pain relief
- Applicant
- Sanuwave, Inc.
- Date received
- 2001-01-12
- Decision date
- 2001-03-30
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- NBN
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Alpharetta, GA
- Statement
- APPROVAL FOR CERTAIN ERGONOMIC AND SAFETY DESIGN CHANGES AND A DEVICE PERFORMANCE CHANGE, I.E., PROVIDING THE OPTION OF USING 4 HZ FREQUENCY OF THE SHOCK WAVE DELIVERY, AS WELL AS LABELING CHANGES IN THE OPERATOR MANUAL TO PROVIDE ADEQUATE INSTRUCTIONS AND INFORMATION ABOUT THESE CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEALTHTRONICS OSSATRON(R) AND IS INDICATED FOR USE FOR PERFORMING EXTRACORPOREAL SHOCK WAVE (ESW) TREATMENT IN PATIENTS WITH CHRONIC PROXIMAL PLANT
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| dermaPACE System (DEN160037) | Sanuwave, Inc. | 2017-12-28 |