NUCLES 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHIL
FDA premarket approval P890027/S001 · decided 1991-09-10
Approval details
- PMA number
- P890027
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- NUCLES 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHIL
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1991-01-08
- Decision date
- 1991-09-10
- Days to decision
- 245 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
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