Esteem
FDA premarket approval P090018/S036 · decided 2017-06-09
Approval details
- PMA number
- P090018
- Supplement
- S036
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Esteem
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Applicant
- Envoy Medical Corporation
- Date received
- 2017-05-10
- Decision date
- 2017-06-09
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- OAF
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- White Bear Lake, MN
- Statement
- New component supplier for the polyether ether ketone (PEEK) overmold component of the Esteem Model 7004/7010 Sensor assemblies and Model 7504/7510 Driver assemblies.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ENVOYCEM, MODEL 1640 (K080032) | Envoy Medical Corporation | 2008-02-28 |