PMA P970051S131

Device: COCHLEAR C1500 SERIES IMPLANTS
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S131
Product code: MCM
Decision date: 2015-11-19
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR THE MANUFACTURING SPECIFICATION TOLERANCES FOR THREE AREAS OF THE TOP SHELL (DEPTH, DOMING IN CENTER, AND FLATNESS OF CHASSIS MATING EDGE), A COMPONENT OF THE IMPLANT CASING.

Current openFDA PMA Record#

Device: COCHLEAR C1500 SERIES IMPLANTS
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S131
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2015-11-19
Decision code: APPR
Date received: 2015-05-18
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE MANUFACTURING SPECIFICATION TOLERANCES FOR THREE AREAS OF THE TOP SHELL (DEPTH, DOMING IN CENTER, AND FLATNESS OF CHASSIS MATING EDGE), A COMPONENT OF THE IMPLANT CASING.