NUCLEUS HYBRID L24 IMPLANT SYSTEM

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Premarket Approval P130016 S002

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 an mr indication at 1. 5 tesla under specific scanning conditions with the magnet surgically removed prior to the mr scan, for the hybrid l24 implant system.

DeviceNUCLEUS HYBRID L24 IMPLANT SYSTEM
Classification NameCochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
Generic NameCochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
ApplicantCochlear Americas
Date Received2014-04-02
Decision Date2014-07-01
PMAP130016
SupplementS002
Product CodePGQ
Advisory CommitteeEar Nose & Throat
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Cochlear Americas 13059 East Peakview Avenue centennial, CO 80111

Supplemental Filings

Supplement NumberDateSupplement Type
P130016Original Filing
S051 2022-09-07 Real-time Process
S050 2022-07-11 30-day Notice
S049 2022-05-02 Normal 180 Day Track No User Fee
S048
S047 2022-02-01 30-day Notice
S046
S045 2020-11-12 30-day Notice
S044
S043 2020-01-14 Special (immediate Track)
S042
S041
S040
S039
S038 2019-06-07 Normal 180 Day Track No User Fee
S037 2019-01-30 30-day Notice
S036 2018-11-01 Normal 180 Day Track
S035 2018-08-13 30-day Notice
S034 2018-02-15 30-day Notice
S033 2018-01-02 30-day Notice
S032 2017-11-13 Normal 180 Day Track
S031 2017-07-17 30-day Notice
S030 2017-06-21 Real-time Process
S029 2017-06-07 30-day Notice
S028 2017-05-23 Normal 180 Day Track
S027 2017-05-16 30-day Notice
S026 2017-04-24 30-day Notice
S025 2017-04-10 30-day Notice
S024 2017-03-23 30-day Notice
S023 2017-02-27 30-day Notice
S022 2016-10-12 Normal 180 Day Track
S021 2016-10-06 Normal 180 Day Track No User Fee
S020 2016-07-25 30-day Notice
S019 2016-06-15 135 Review Track For 30-day Notice
S018 2016-02-24 30-day Notice
S017 2016-02-24 Normal 180 Day Track
S016 2016-02-08 Normal 180 Day Track
S015 2016-01-06 30-day Notice
S014 2016-01-05 30-day Notice
S013 2015-12-04 30-day Notice
S012 2015-11-23 Normal 180 Day Track
S011 2015-02-13 30-day Notice
S010 2014-12-24 30-day Notice
S009 2014-09-24 Normal 180 Day Track No User Fee
S008 2014-07-23 30-day Notice
S007 2014-06-09 Real-time Process
S006 2014-05-16 30-day Notice
S005 2014-05-01 Normal 180 Day Track
S004 2014-04-18 Normal 180 Day Track No User Fee
S003 2014-04-18 Normal 180 Day Track No User Fee
S002 2014-04-02 Real-time Process
S001 2014-03-28 30-day Notice

NIH GUDID Devices

Device IDPMASupp
09321502012089 P130016 000
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09321502023962 P130016 000
09321502023313 P130016 000
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09321502024099 P130016 000
09321502024075 P130016 000
09321502022859 P130016 000

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