PMA P000015S026

Device: Nucleus Auditory Brainstem Implant System
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S026
Product code: MHE
Decision date: 2018-02-14
Classification: Implant, Auditory Brainstem
Generic name: Implant, auditory brainstem
Approval order statement: Approval for the use of coupons for residual gas analysis (RGA) testing for hermeticity and to remove the requirement of batch release based on RGA testing.

Current openFDA PMA Record#

Device: Nucleus Auditory Brainstem Implant System
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S026
Product code: MHE
Generic name: Implant, auditory brainstem
Decision date: 2018-02-14
Decision code: APPR
Date received: 2017-08-25
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the use of coupons for residual gas analysis (RGA) testing for hermeticity and to remove the requirement of batch release based on RGA testing.