Nucleus Hybrid L24 Implant System

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Premarket Approval P130016 S032

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 modifications to the firmware and software of the nucleus 7 system as well as a modification to the custom sound ep used with the nucleus 6 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 Received2017-11-13
Decision Date2018-06-13
PMAP130016
SupplementS032
Product CodePGQ
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 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
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