PMA P960058S084

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S084
Product code: MCM
Decision date: 2010-08-20
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL TO UPDATE THE MANUFACTURING SPECIFICATION FOR THE FINAL MOLD PROCESS OF THE COIL-CASE/ELECTRODE SUBASSEMBLY TO REPLACE MANUAL SILICONE INJECTION WITH AN AUTOMATED DISPENSING MECHANISM.

Current openFDA PMA Record#

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S084
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2010-08-20
Decision code: APPR
Date received: 2010-04-07
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO UPDATE THE MANUFACTURING SPECIFICATION FOR THE FINAL MOLD PROCESS OF THE COIL-CASE/ELECTRODE SUBASSEMBLY TO REPLACE MANUAL SILICONE INJECTION WITH AN AUTOMATED DISPENSING MECHANISM.