PMA P000015S018

Device: NUCLEUS AUDITORY BRAINSTEM IMPLANT
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S018
Product code: MHE
Decision date: 2016-12-21
Classification: Implant, Auditory Brainstem
Generic name: Implant, auditory brainstem
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 AUDITORY BRAINSTEM IMPLANT
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S018
Product code: MHE
Generic name: Implant, auditory brainstem
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.