PMA P970051S104

Device: NUCLEUS COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S104
Product code: MCM
Decision date: 2013-10-23
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR THE FOLLOWING CHANGES: A MODIFICATION TO THE FREEDOM SOUND PROCESSOR, A CHANGE IN THE FREEDOM BODYWORN CABLE O-RING, A CHANGE TO FREEDOM BODYWORN CABLE CLIP, A CHANGE TO THE FREEDOM BATTERY PACK, A CHANGE TO THE FREEDOM RECHARGEABLE BATTERY,AND A MODIFICATION OF THE SURGICAL TOOL KIT INSTRUCTIONS FOR THE CI24RE AND CI422 SERIES IMPLANTS.

Current openFDA PMA Record#

Device: NUCLEUS COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S104
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2013-10-23
Decision code: APPR
Date received: 2013-01-16
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE FOLLOWING CHANGES: A MODIFICATION TO THE FREEDOM SOUND PROCESSOR, A CHANGE IN THE FREEDOM BODYWORN CABLE O-RING, A CHANGE TO FREEDOM BODYWORN CABLE CLIP, A CHANGE TO THE FREEDOM BATTERY PACK, A CHANGE TO THE FREEDOM RECHARGEABLE BATTERY,AND A MODIFICATION OF THE SURGICAL TOOL KIT INSTRUCTIONS FOR THE CI24RE AND CI422 SERIES IMPLANTS.