CALRION CII BIONIC EAR SYSTEM (ADULT)

FDA premarket approval P940022/S027 · decided 2002-11-06

Approval details

PMA number

P940022

Supplement

S027

Supplement type

Real-Time Process

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

CALRION CII BIONIC EAR SYSTEM (ADULT)

Generic name

Implant, cochlear

Applicant

Advanced Bionics Corp.

Date received

2002-10-25

Decision date

2002-11-06

Days to decision

12 days

Decision code

APPR

Product code

MCM

Advisory committee

Ear, Nose, Throat

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR A REVISION TO THE PACKAGE INSERT (DOCUMENT NUMBER 9196252-001) THAT MODIFIED THE PERCENTAGE OF PATIENTS WHO PREFERRED HIGH RESOLUTION SOUND PROCESSING TO CONVENTIONAL SOUND PROCESSING. THIS MODIFICATION IS BASED ON UPDATED DATA RECEIVED FROM PATIENTS AT THE 12-MONTH FOLLOW-UP VISIT WHICH SHOWED THAT THREE OF THE FIVE PATIENTS WHO ORIGINALLY PREFERRED THEIR CONVENTIONAL STRATEGY AT THE THREE-MONTH EXPERIMENTAL STRATEGY VISIT SWITCHED THEIR PREFERENCE TO HIRES. THUS, 48 OF 50 PATIENTS