HEALTHTRONICS OSSATRON
FDA premarket approval P990086/S001 · decided 2001-05-01
Approval details
- PMA number
- P990086
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- HEALTHTRONICS OSSATRON
- Generic name
- Generator, shock-wave, for pain relief
- Applicant
- Sanuwave, Inc.
- Date received
- 2000-10-19
- Decision date
- 2001-05-01
- Days to decision
- 194 days
- Decision code
- APPR
- Product code
- NBN
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Alpharetta, GA
- Statement
- APPROVAL FOR THE POST MARKET APPROVAL STUDY PROTOCOL.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| dermaPACE System (DEN160037) | Sanuwave, Inc. | 2017-12-28 |