ESTEEM SYSTEM
FDA premarket approval P090018/S020 · decided 2013-06-06
Approval details
- PMA number
- P090018
- Supplement
- S020
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ESTEEM SYSTEM
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Applicant
- Envoy Medical Corporation
- Date received
- 2013-05-01
- Decision date
- 2013-06-06
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- OAF
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- White Bear Lake, MN
- Statement
- APPROVAL FOR ADDITION OF TECHNICAL NOTES TO EXPAND UPON THE INFORMATION IN THE AUDIOLOGISTS MANUAL AND TO REMIND SURGEONS AND AUDIOLOGISTS OF THE IMPORTANCE OF REPORTING SIGNIFICANT INJURIES TO CRANIAL NERVE VII VIA THE MEDICAL DEVICE REPORTING SYSTEM.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ENVOYCEM, MODEL 1640 (K080032) | Envoy Medical Corporation | 2008-02-28 |