NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI
FDA premarket approval P840024/S012 · decided 1987-11-17
Approval details
- PMA number
- P840024
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1987-08-24
- Decision date
- 1987-11-17
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
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