PMA P960058S030

Device: HIRESOLUTION BIONIC EAR SYSTEM (HIRES 90K)
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S030
Product code: MCM
Decision date: 2003-07-07
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR THE REPACKAGED ICS (IMPLANTABLE COCHLEAR STIMULATOR), REFERRED TO AS HIRES 90K, AND ITS ASSOCIATED SURGICAL TOOLS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIRESOLUTION BIONIC EAR SYSTEM AND IS INDICATED FOR ADULTS AND THE PEDIATRIC POPULATION AGED 12-MONTHS THROUGH 17 YEARS, 11-MONTHS OF AGE.

Current openFDA PMA Record#

Device: HIRESOLUTION BIONIC EAR SYSTEM (HIRES 90K)
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S030
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2003-07-07
Decision code: APPR
Date received: 2003-03-18
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE REPACKAGED ICS (IMPLANTABLE COCHLEAR STIMULATOR), REFERRED TO AS HIRES 90K, AND ITS ASSOCIATED SURGICAL TOOLS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIRESOLUTION BIONIC EAR SYSTEM AND IS INDICATED FOR ADULTS AND THE PEDIATRIC POPULATION AGED 12-MONTHS THROUGH 17 YEARS, 11-MONTHS OF AGE.