NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT (ABI)

Implant, Cochlear

FDA Premarket Approval P000015 S005

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 the addition of a polyterephthalate (pet) mesh disk. The device, as modified, will be marketed under the trade name nucleus 24 auditory brainstem implant with pet mesh disk and is intended to restore useful hearing in individuals with neurofibromatosis type 2 (nf2) who are 12 years of age or older, via electrical stimulation of the cochlear nucleus.

DeviceNUCLEUS 24 AUDITORY BRAINSTEM IMPLANT (ABI)
Classification NameImplant, Cochlear
Generic NameImplant, Cochlear
ApplicantCochlear Americas
Date Received2003-06-24
Decision Date2003-08-22
PMAP000015
SupplementS005
Product CodeMCM
Advisory CommitteeEar Nose & Throat
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Cochlear Americas 13059 East Peakview Avenue centennial, CO 80111

Supplemental Filings

Supplement NumberDateSupplement Type
P000015Original Filing
S048 2022-09-07 Real-time Process
S047 2022-04-26 Normal 180 Day Track
S046 2021-06-21 135 Review Track For 30-day Notice
S045 2020-11-12 30-day Notice
S044
S043 2020-07-15 30-day Notice
S042 2019-11-13 30-day Notice
S041
S040
S039 2019-07-31 30-day Notice
S038
S037 2019-06-06 30-day Notice
S036
S035 2019-01-30 30-day Notice
S034 2018-11-01 Normal 180 Day Track
S033 2018-08-13 30-day Notice
S032 2018-04-13 30-day Notice
S031 2018-02-15 30-day Notice
S030 2018-02-02 30-day Notice
S029 2018-01-02 30-day Notice
S028 2018-01-02 30-day Notice
S027 2017-11-13 Normal 180 Day Track
S026 2017-08-25 135 Review Track For 30-day Notice
S025 2017-08-07 30-day Notice
S024 2017-07-26 30-day Notice
S023 2017-06-21 Real-time Process
S022 2017-06-07 30-day Notice
S021 2017-05-16 30-day Notice
S020 2017-04-10 30-day Notice
S019 2017-03-23 30-day Notice
S018 2016-11-23 30-day Notice
S017 2016-11-23 30-day Notice
S016 2016-10-12 Normal 180 Day Track
S015 2016-09-22 30-day Notice
S014 2016-06-23 30-day Notice
S013
S012 2015-12-18 Normal 180 Day Track
S011 2009-10-13 Special (immediate Track)
S010 2007-12-03 Real-time Process
S009
S008 2006-09-05 30-day Notice
S007
S006 2005-03-09 30-day Notice
S005 2003-06-24 Real-time Process
S004 2002-12-06 Normal 180 Day Track
S003 2002-10-31 Normal 180 Day Track
S002 2001-07-23 Normal 180 Day Track
S001 2001-06-22 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
09321502020404 P000015 012

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