Nucleus CI632 Cochlear Implant, Nucleus CI532 Cochlear Implant
FDA premarket approval P970051/S231 · decided 2024-11-15
Approval details
- PMA number
- P970051
- Supplement
- S231
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Nucleus CI632 Cochlear Implant, Nucleus CI532 Cochlear Implant
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2024-10-17
- Decision date
- 2024-11-15
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- introduction of EA32 production lines in the new cleanroom 5 at the Lane Cove Manufacturing Site
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