COCHLEAR NUCLEUS C1512 IMPLANT SYSTEM
FDA premarket approval P970051/S124 · decided 2014-12-12
Approval details
- PMA number
- P970051
- Supplement
- S124
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COCHLEAR NUCLEUS C1512 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 A MISALIGNMENT BETWEEN INSPECTIONS CONDUCTED POST-TOP SHELL FILL MOLDING AND THE SILICONE FINISHING INSPECTION AT SUBSEQUENT OPERATIONS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.