PMA P970051S154

Device: NUCLEUS COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S154
Product code: MCM
Decision date: 2016-12-21
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: Introduce a semi-automatic process that uses silicone molding tools as an alternate to the manual silicone molding process currently used in the top shell underfill process for the implant.

Current openFDA PMA Record#

Device: NUCLEUS COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S154
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2016-12-21
Decision code: OK30
Date received: 2016-11-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Introduce a semi-automatic process that uses silicone molding tools as an alternate to the manual silicone molding process currently used in the top shell underfill process for the implant.