NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA premarket approval P890027/S040 · decided 1998-06-26
Approval details
- PMA number
- P890027
- Supplement
- S040
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1997-09-25
- Decision date
- 1998-06-26
- Days to decision
- 274 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for a New Sterilizatin facility located at Cochlear Limited, 14 Mars Road, Lane Cove, New South Wales 2066, Australia.
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