ESTEEM IMPLANTABLE HEARING SYSTEM
FDA premarket approval P090018/S019 · decided 2013-05-17
Approval details
- PMA number
- P090018
- Supplement
- S019
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ESTEEM IMPLANTABLE HEARING SYSTEM
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Applicant
- Envoy Medical Corporation
- Date received
- 2013-04-19
- Decision date
- 2013-05-17
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- OAF
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- White Bear Lake, MN
- Statement
- APPROVAL FOR THE FOLLOWING: 1) REVISIONS TO THE INSTRUCTIONS FOR USE FOR THE IMPLANTING SURGEON; 2) A MANUAL TO INFORM AUDIOLOGISTS ON THE PROGRAMMING OF THE ESTEEM SYSTEM; AND 3) FOR MAKING MANUALS, WHICH ARE MADE REDUNDANT BY THE FORMER LABELING CHANGES, OBSOLETE.
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 |