PMA P960058S089

Device: AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S089
Product code: MCM
Decision date: 2011-11-17
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR A NEW OFF-THE-EAR SOUND PROCESSOR CALLED NEPTUNE AND ITS ASSOCIATED ACCESSORIES. THE NEPTUNE PROCESSOR, WHEN USED WITH THE NEW AQUAMIC HEADPIECE, IS WATERPROOF. IN ADDITION, A NEW VERSION OF SOUNDWAVE PROFESSIONAL SOFTWARE SUITE (SOUNDWAVE 2.1) IS INCLUDED IN THE SUPPLEMENT.

Current openFDA PMA Record#

Device: AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S089
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2011-11-17
Decision code: APPR
Date received: 2011-06-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A NEW OFF-THE-EAR SOUND PROCESSOR CALLED NEPTUNE AND ITS ASSOCIATED ACCESSORIES. THE NEPTUNE PROCESSOR, WHEN USED WITH THE NEW AQUAMIC HEADPIECE, IS WATERPROOF. IN ADDITION, A NEW VERSION OF SOUNDWAVE PROFESSIONAL SOFTWARE SUITE (SOUNDWAVE 2.1) IS INCLUDED IN THE SUPPLEMENT.