ESTEEM
FDA premarket approval P090018/S030 · decided 2016-03-18
Approval details
- PMA number
- P090018
- Supplement
- S030
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- ESTEEM
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Applicant
- Envoy Medical Corporation
- Date received
- 2015-09-23
- Decision date
- 2016-03-18
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- OAF
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- White Bear Lake, MN
- Statement
- Approval of the following changes to the post-approval study for your device:change in sample size, removal of blinded audiologists, removal of requirement for x-ray ofimplanted device, change in follow-up point of evaluation and data gathering for safety objective.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ENVOYCEM, MODEL 1640 (K080032) | Envoy Medical Corporation | 2008-02-28 |