PMA P970051S136

Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S136
Product code: MCM
Decision date: 2015-11-20
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: THE INTRODUCTION OF AN ADDITIONAL CLEANING STEP TO REMOVE PRIMER RESIDUE PRIOR TO CURING FROM THE WELD SURFACE OF THE NUCLEUS CI 500 SERIES IMPLANTS (NUCLEUS CI512 AND 522).

Current openFDA PMA Record#

Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S136
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2015-11-20
Decision code: OK30
Date received: 2015-10-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: THE INTRODUCTION OF AN ADDITIONAL CLEANING STEP TO REMOVE PRIMER RESIDUE PRIOR TO CURING FROM THE WELD SURFACE OF THE NUCLEUS CI 500 SERIES IMPLANTS (NUCLEUS CI512 AND 522).