PMA P960058S118

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S118
Product code: MCM
Decision date: 2015-09-18
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: CHANGE IN LOCATION OF THE SUPPLIER OF RAW POLYETHYLENE MATERIALUSED TO MANUFACTURE BRAIDED FIBER THAT IS THEN USED IN THE HIRES 90KTM ADVANTAGE ANTENNA COIL, AND EXPANDED MATERIAL SPECIFICATIONS FOR BOTH THE RAW FIBER AND THE BRAIDED FIBER.

Current openFDA PMA Record#

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S118
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2015-09-18
Decision code: OK30
Date received: 2015-08-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN LOCATION OF THE SUPPLIER OF RAW POLYETHYLENE MATERIALUSED TO MANUFACTURE BRAIDED FIBER THAT IS THEN USED IN THE HIRES 90KTM ADVANTAGE ANTENNA COIL, AND EXPANDED MATERIAL SPECIFICATIONS FOR BOTH THE RAW FIBER AND THE BRAIDED FIBER.