ESTEEM
FDA premarket approval P090018/S026 · decided 2014-08-21
Approval details
- PMA number
- P090018
- Supplement
- S026
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ESTEEM
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Applicant
- Envoy Medical Corporation
- Date received
- 2014-05-23
- Decision date
- 2014-08-21
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- OAF
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- White Bear Lake, MN
- Statement
- APPROVAL FOR SOFTWARE CHANGES THAT HAVE BEEN MADE TO THE ESTEEMCOMMANDER IN VERSION 3.0.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ENVOYCEM, MODEL 1640 (K080032) | Envoy Medical Corporation | 2008-02-28 |