NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S128 · decided 2015-03-13
Approval details
- PMA number
- P970051
- Supplement
- S128
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2015-02-13
- Decision date
- 2015-03-13
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- ADDITION OF THE HELIUM BOMBING, AND REMOVAL OF GROSS LEAK TEST FOR THE MAGNET ASSEMBLY.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.