ESTEEM
FDA premarket approval P090018/S011 · decided 2012-11-13
Approval details
- PMA number
- P090018
- Supplement
- S011
- Supplement type
- 135 Review Track For 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
- 2011-06-14
- Decision date
- 2012-11-13
- Days to decision
- 518 days
- Decision code
- APPR
- Product code
- OAF
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- White Bear Lake, MN
- Statement
- APPROVAL FOR THE EO STERILIZATION LOAD CONFIGURATION CHANGE FOR THE ESTEEM PRODUCT FAMILY.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ENVOYCEM, MODEL 1640 (K080032) | Envoy Medical Corporation | 2008-02-28 |