HEALTHTRONICS OSSATRON
FDA premarket approval P990086/S004 · decided 2004-08-06
Approval details
- PMA number
- P990086
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- 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
- 2004-02-09
- Decision date
- 2004-08-06
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- NBN
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Alpharetta, GA
- Statement
- APPROVAL FOR INSERTION OF A TABLE OF ADVERSE EVENTS AND A BRIEF PARAGRAPH FOLLOWING THE POST-APPROVAL STUDY OF ESW TREATMENT OF PLANTAR FASCIITIS CONSTITUTING THE LABELING CHANGES IN THE OPERATING MANUAL.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| dermaPACE System (DEN160037) | Sanuwave, Inc. | 2017-12-28 |