PMA P000025S079

Device: COMBI 40+ COCHLEAR IMPLANT SYSTEM
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S079
Product code: MCM
Decision date: 2015-01-20
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR THE MI1200 SYNCHRONY AND MI1200 SYNCHRONY PINCOCHLEAR IMPLANTS, EACH WITH ELECTRODE VARIANTS +STANDARD, +MEDIUM, +COMPRESSED, GB, +FLEX24, +FLEX28, ASSOCIATED SURGICAL TOOLS, REPLACEMENT IMPLANT MAGNET AND NON-MAGNETIC SPACER, AND COMPATIBLE MAGNETS FOR EXTERNAL COMPONENTS.

Current openFDA PMA Record#

Device: COMBI 40+ COCHLEAR IMPLANT SYSTEM
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S079
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2015-01-20
Decision code: APPR
Date received: 2014-06-09
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE MI1200 SYNCHRONY AND MI1200 SYNCHRONY PINCOCHLEAR IMPLANTS, EACH WITH ELECTRODE VARIANTS +STANDARD, +MEDIUM, +COMPRESSED, GB, +FLEX24, +FLEX28, ASSOCIATED SURGICAL TOOLS, REPLACEMENT IMPLANT MAGNET AND NON-MAGNETIC SPACER, AND COMPATIBLE MAGNETS FOR EXTERNAL COMPONENTS.