ESTEEM SYSTEM
FDA premarket approval P090018/S025 · decided 2014-04-08
Approval details
- PMA number
- P090018
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ESTEEM SYSTEM
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Applicant
- Envoy Medical Corporation
- Date received
- 2014-03-12
- Decision date
- 2014-04-08
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OAF
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- White Bear Lake, MN
- Statement
- ACCEPTANCE OF A MANUFACTURING PROCESS CHANGE FOR THE ESTEEM SYSTEM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ENVOYCEM, MODEL 1640 (K080032) | Envoy Medical Corporation | 2008-02-28 |