NUCLEUS 22 CHANNEL COCHLEAR IMPLANT

Implant, Cochlear

FDA Premarket Approval P890027 S031

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for modifications to the external transmitter coil of the nucleus 22 channel cochlear implant device. The modifications consist of connecting two diodes in parallel with the external transmitter coil to limit esd energy being transmitted to the implant by the coil. A change in the manufacturing method for the coil windings will also reduce the effective coil diameter by approximately 0. 1mm.

DeviceNUCLEUS 22 CHANNEL COCHLEAR IMPLANT
Classification NameImplant, Cochlear
Generic NameImplant, Cochlear
ApplicantCochlear Americas
Date Received1996-04-24
Decision Date1996-05-20
PMAP890027
SupplementS031
Product CodeMCM
Advisory CommitteeEar Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Cochlear Americas 13059 E Peakview Ave centennial, CO 80111

Supplemental Filings

Supplement NumberDateSupplement Type
P890027Original Filing
S062 2022-04-26 Normal 180 Day Track
S061
S060 2019-08-15 Normal 180 Day Track
S059 2017-05-23 Normal 180 Day Track
S058 2017-02-09 Special (immediate Track)
S057 2009-10-13 Special (immediate Track)
S056 2007-09-14 Real-time Process
S055 2002-12-16 Real-time Process
S054 2002-12-06 Normal 180 Day Track
S053 2002-10-31 Normal 180 Day Track
S052 2002-08-28 Special (immediate Track)
S051 2001-09-28 Normal 180 Day Track
S050 2001-04-19 Normal 180 Day Track
S049 2000-11-29 Normal 180 Day Track
S048 1999-10-20 Real-time Process
S047 1999-04-15 30-day Notice
S046 1998-09-21 Real-time Process
S045 1998-08-17 Normal 180 Day Track
S044 1998-03-18 30-day Notice
S043 1998-02-09 Special (immediate Track)
S042 1997-12-09 Normal 180 Day Track
S041 1997-10-02 Normal 180 Day Track
S040 1997-09-25 Normal 180 Day Track
S039 1997-07-01 Normal 180 Day Track
S038 1997-04-24 Normal 180 Day Track
S037 1997-02-18 Normal 180 Day Track
S036 1996-08-07 Normal 180 Day Track
S035 1996-06-20 Normal 180 Day Track
S034 1996-06-06 Normal 180 Day Track
S033 1996-05-06 Normal 180 Day Track
S032 1996-04-25 Special (immediate Track)
S031 1996-04-24 Normal 180 Day Track
S030 1996-02-23 Normal 180 Day Track
S029 1995-11-24 Normal 180 Day Track
S028 1995-10-31 Normal 180 Day Track
S027 1995-03-03 Normal 180 Day Track
S026 1995-02-28 Normal 180 Day Track
S025 1994-10-04 Normal 180 Day Track
S024
S023 1994-05-27 Normal 180 Day Track
S022 1994-05-06 Normal 180 Day Track
S021 1993-09-30 Normal 180 Day Track
S020 1993-09-01 Normal 180 Day Track
S019 1993-07-07 Normal 180 Day Track
S018 1993-06-03 Normal 180 Day Track
S017 1992-09-08 Normal 180 Day Track
S016 1992-08-13 Normal 180 Day Track
S015 1992-07-23 Normal 180 Day Track
S014 1992-04-09 Normal 180 Day Track
S013 1992-04-09 Normal 180 Day Track
S012 1992-02-06 Normal 180 Day Track
S011 1992-02-06 Normal 180 Day Track
S010 1992-01-21 Normal 180 Day Track
S009 1992-01-13 Normal 180 Day Track
S008 1991-12-24 Normal 180 Day Track
S007 1991-11-15 Normal 180 Day Track
S006 1991-09-20 Normal 180 Day Track
S005 1991-08-22 Normal 180 Day Track
S004 1991-05-31 Normal 180 Day Track
S003 1991-03-27 Normal 180 Day Track
S002 1991-02-28 Normal 180 Day Track
S001 1991-01-08 Normal 180 Day Track

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