Hybrid L24 CI System
FDA premarket approval P130016/S038 · decided 2019-12-04
Approval details
- PMA number
- P130016
- Supplement
- S038
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Hybrid L24 CI System
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Cochlear Americas
- Date received
- 2019-06-07
- Decision date
- 2019-12-04
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for a manufacturing site located at Cochlear Malaysia Sdn Bhd, Unit UG-1, Upper Ground Floor, Vertical Podium, Avenue 3, Bangsar South, No. 8 Jalan Kerinchi, 59200 Kuala Lumpur, Malaysia, for two sound processing units: the CP910 and CP920.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.