PMA P940022S010

Device
CLARION MULTI-STRATEGY COCHLEAR IMPLANT(ADULT)
Applicant
Advanced Bionics Corp.
PMA number
P940022
Supplement
S010
Product code
MCM
Decision date
1999-03-22
Generic name
Implant, cochlear
Approval order statement
Approval for an alternate sterilization site located at Griffith Micro Science, Inc., 5725 West Harold Gatty Drive, Salt Lake City, Utah 84116.

Current openFDA PMA Record#

Device
CLARION MULTI-STRATEGY COCHLEAR IMPLANT(ADULT)
Applicant
Advanced Bionics Corp.
PMA number
P940022
Supplement
S010
Product code
MCM
Generic name
Implant, cochlear
Decision date
1999-03-22
Decision code
APPR
Date received
1999-02-04
Supplement type
Normal 180 Day Track
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for an alternate sterilization site located at Griffith Micro Science, Inc., 5725 West Harold Gatty Drive, Salt Lake City, Utah 84116.