PMA P130016S038

Device: Hybrid L24 CI System
Applicant: Cochlear Americas
PMA number: P130016
Supplement: S038
Product code: PGQ
Decision date: 2019-12-04
Generic name: Cochlear implant with combined electrical stimulation and acoustic amplification
Approval order 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.

Current openFDA PMA Record#

Device: Hybrid L24 CI System
Applicant: Cochlear Americas
PMA number: P130016
Supplement: S038
Product code: PGQ
Generic name: Cochlear implant with combined electrical stimulation and acoustic amplification
Decision date: 2019-12-04
Decision code: APPR
Date received: 2019-06-07
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.