PMA P000025S019

Device: COMBI 40+ SYSTEM WITH C40+ OR PULSARCI100 COCHLEAR IMPLANTS
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S019
Product code: MCM
Decision date: 2005-07-25
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR THE COMBI 40+ SYSTEM WITH C40+ OR PULSARCI100 COCHLEAR IMPLANTS TO UPDATE NON-ESSENTIAL LABELING AND A MANUAL FOR TROUBLESHOOTING FM SYSTEMS WHICH MAY BE USED ITH THE TEMPO+.

Current openFDA PMA Record#

Device: COMBI 40+ SYSTEM WITH C40+ OR PULSARCI100 COCHLEAR IMPLANTS
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S019
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2005-07-25
Decision code: APPR
Date received: 2005-07-05
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE COMBI 40+ SYSTEM WITH C40+ OR PULSARCI100 COCHLEAR IMPLANTS TO UPDATE NON-ESSENTIAL LABELING AND A MANUAL FOR TROUBLESHOOTING FM SYSTEMS WHICH MAY BE USED ITH THE TEMPO+.