PMA P970051S147

Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S147
Product code: MCM
Decision date: 2016-10-28
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: Approval to outsource the piercing of the hermetization hole in the top shell to an approved supplier for the CI24RE(ST), CI24RE(CA), CI422 and Hybrid L24 implants.

Current openFDA PMA Record#

Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S147
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2016-10-28
Decision code: APPR
Date received: 2016-06-15
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to outsource the piercing of the hermetization hole in the top shell to an approved supplier for the CI24RE(ST), CI24RE(CA), CI422 and Hybrid L24 implants.