NUCLEUS HYBRID L24 IMPLANT SYSTEM
FDA premarket approval P130016/S001 · decided 2014-04-25
Approval details
- PMA number
- P130016
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NUCLEUS HYBRID L24 IMPLANT SYSTEM
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Cochlear Americas
- Date received
- 2014-03-28
- Decision date
- 2014-04-25
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- ACCEPTANCE OF A SUPPLIER MANUFACTURING PROCESS CHANGE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.