NUCLEUS C1512 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S125 · decided 2014-12-12
Approval details
- PMA number
- P970051
- Supplement
- S125
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NUCLEUS C1512 COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2014-11-12
- Decision date
- 2014-12-12
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- UPDATE THE ELECTRONIC ASSEMBLY INSPECTION STANDARD AND ALIGN THE ELECTRONIC ASSEMBLY INSPECTION STANDARD WITH THE CURRENT INSPECTION STANDARDS FOR THE NUCLEUS COCHLEAR IMPLANT SYSTEM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.