PMA P840024S081

Device: NUCLEUS 22 COCHLEAR IMPLANT SYSTEM FOR ADULTS
Applicant: Cochlear Americas
PMA number: P840024
Supplement: S081
Product code: MCM
Decision date: 2001-07-24
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR THE CRYSTAL INTEGRITY TEST SYSTEM THAT PROVIDES A WAY OF PERFORMING A SERIES OF INTEGRITY CHECKS ON EITHER CURRENT OR PAST GENERATION NUCLEUS COCHLEAR IMPLANTS.

Current openFDA PMA Record#

Device: NUCLEUS 22 COCHLEAR IMPLANT SYSTEM FOR ADULTS
Applicant: Cochlear Americas
PMA number: P840024
Supplement: S081
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2001-07-24
Decision code: APPR
Date received: 2001-04-19
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE CRYSTAL INTEGRITY TEST SYSTEM THAT PROVIDES A WAY OF PERFORMING A SERIES OF INTEGRITY CHECKS ON EITHER CURRENT OR PAST GENERATION NUCLEUS COCHLEAR IMPLANTS.