NUCLEUS 22 CHANNEL COCHLEAR IMPLANT
FDA premarket approval P890027/S035 · decided 1996-08-28
Approval details
- PMA number
- P890027
- Supplement
- S035
- 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
- 1996-06-20
- Decision date
- 1996-08-28
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR IMPLEMENTING A NEW DIAGNOSTIC AND PROGRAMMING SYSTEM SOFTWARE. THIS VERSION OF SOFTWARE IS THE DPS VERSION 6.125. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM, DPS SOFTWARE VERSION 6.125.
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