S-Series™ Speech Processor

Basic Information

• Brand Name: S-Series™ Speech Processor
• Primary DI: 07630016805301
• Version / Model: AB-7200
• Company Name: Advanced Bionics AG
• Labeler DUNS: 485262658
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-05
• Public Version: 5
• Public Version Date: 2022-04-08
• Public Version Status: Update
• Public Device Record Key: 25ec8ddf-18d2-451e-bff6-3cfe20d76d26

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MCM	IMPLANT, COCHLEAR	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47374	Cochlear implant/auditory brainstem implant sound processor	An external component of a cochlear implant (CI) or auditory brainstem implant system that typically consists of a battery-powered microphone/transmitter (transducer) designed to convert sound waves from the environment into electrical signals which are transmitted to the implantable portion of the system, via a coil (which may or may not be included), for the partial restoration of auditory sensation in a severely/profoundly deaf person. Also known as a speech processor, it is typically worn like a behind-the-ear (BTE) or off-the-ear (OTE) hearing aid.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07630016805301	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P960058	001