NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S023 · decided 2002-12-09
Approval details
- PMA number
- P970051
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2002-10-31
- Decision date
- 2002-12-09
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR EXPANSION OF THE MANUFACTURING FACILITY LOCATED AT COCHLEAR LIMITED, LANE COVE, AUSTRALIA.
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