ESTEEM
FDA premarket approval P090018/S001 · decided 2011-05-06
Approval details
- PMA number
- P090018
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ESTEEM
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Applicant
- Envoy Medical Corporation
- Date received
- 2010-04-07
- Decision date
- 2011-05-06
- Days to decision
- 394 days
- Decision code
- APPR
- Product code
- OAF
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- White Bear Lake, MN
- Statement
- APPROVAL FOR THE LEAD DESIGN (MODEL 7004/7504 LEADS) AND LEAD MANUFACTURING SITE CHANGE (ENVOY MEDICAL CORP., ST. PAUL, MINNESOTA).
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 |