Esteem
FDA premarket approval P090018/S039 · decided 2020-02-24
Approval details
- PMA number
- P090018
- Supplement
- S039
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Esteem
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Applicant
- Envoy Medical Corporation
- Date received
- 2019-09-05
- Decision date
- 2020-02-24
- Days to decision
- 172 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 (i.e., the New Enrollment 2 study, approved under P090018/S030) for your device: (a) use the evaluable bone conduction data at 1 month as a safety endpoint to measure cochlear stability collected from the 45 subjects used for the efficacy endpoints (SRT and WRS), and (b) supplement the AE safety endpoints (SAEs including facial paresis/paralysis at 1 month) with data from a retrospective review of charts from patients not participating
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ENVOYCEM, MODEL 1640 (K080032) | Envoy Medical Corporation | 2008-02-28 |