PMA P960058S042

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S042
Product code: MCM
Decision date: 2005-09-21
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR A MANUFACTURING SITE FOR RECEIVING, RECEIVING INSPECTION, STAGING, PACKAGING FINISHED GOODS, AND SHIPPING LOCATED AT ADVANCED BIONICS, SYLMAR, CALIFORNIA.

Current openFDA PMA Record#

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S042
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2005-09-21
Decision code: APPR
Date received: 2005-05-03
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE FOR RECEIVING, RECEIVING INSPECTION, STAGING, PACKAGING FINISHED GOODS, AND SHIPPING LOCATED AT ADVANCED BIONICS, SYLMAR, CALIFORNIA.