Esteem® Totally Implantable Hearing System
FDA premarket approval P090018/S041 · decided 2022-08-24
Approval details
- PMA number
- P090018
- Supplement
- S041
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Esteem® Totally Implantable Hearing System
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Applicant
- Envoy Medical Corporation
- Date received
- 2022-03-23
- Decision date
- 2022-08-24
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- OAF
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- White Bear Lake, MN
- Statement
- Approval of final labeling changes for the post-approval study (PAS) referenced above. The updates to the final PAS labeling have been submitted to comply with the conditions of approval outlined in our approval order for P090018.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ENVOYCEM, MODEL 1640 (K080032) | Envoy Medical Corporation | 2008-02-28 |