NUCLEUS 22 CHANNEL COCHLEAR IMPLANT
FDA premarket approval P890027/S019 · decided 1994-03-30
Approval details
- PMA number
- P890027
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 22 CHANNEL COCHLEAR IMPLANT
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1993-07-07
- Decision date
- 1994-03-30
- Days to decision
- 266 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.