NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (ABI)

Implant, Cochlear

FDA Premarket Approval P000015 S008

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

Additional ethylene oxide (eo) sterilizer and change to a new size of ethylene oxide canister.

DeviceNUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (ABI)
Classification NameImplant, Cochlear
Generic NameImplant, Cochlear
ApplicantCochlear Americas
Date Received2006-09-05
Decision Date2006-10-05
PMAP000015
SupplementS008
Product CodeMCM
Advisory CommitteeEar Nose & Throat
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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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