HEALTHTRONICS OSSATRON
FDA premarket approval P990086 · decided 2000-10-12
Approval details
- PMA number
- P990086
- Trade name
- HEALTHTRONICS OSSATRON
- Generic name
- Generator, shock-wave, for pain relief
- Applicant
- Sanuwave, Inc.
- Date received
- 1999-12-30
- Decision date
- 2000-10-12
- Days to decision
- 287 days
- Decision code
- APWD
- Product code
- NBN
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Alpharetta, GA
- Statement
- THIS DEVICE IS INDICATED FOR USE FOR PERFORMING EXTRACORPOREAL SHOCK WAVE TREATMENT IN PATIENTS WITH CHRONIC PROXIMAL PLANTAR FASCIITIS THAT HAS FAILED TO RESPOND TO CONSERVATIVE TREATMENT. CHRONIC PROXIMAL PLANTAR FASCIITIS IS DEFINED AS PAIN IN THE AREA OF THE INSERTION OF THE PLANTAR FASCIA ON THE MEDIAL CALCANEAL TUBEROSITY THAT HAS PERSISTED FOR SIX MONTHS OR MORE.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| dermaPACE System (DEN160037) | Sanuwave, Inc. | 2017-12-28 |