NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S059 · decided 2010-08-20
Approval details
- PMA number
- P970051
- Supplement
- S059
- Supplement type
- 135 Review Track For 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
- 2009-11-09
- Decision date
- 2010-08-20
- Days to decision
- 284 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL TO ADD AN N-HEPTANE WASH OF THE IMPLANT PRIOR TO OVER-MOLDING.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.