Nucleus Hybrid L24 Implant System

FDA Premarket Approval P130016 S049

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

DeviceNucleus Hybrid L24 Implant System
Generic NameCochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
ApplicantCochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP130016 Supplement NumberS049 Date Received05/02/2022 Decision Date06/16/2022 Product Code PGQ  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
Date Received2022-05-02
Decision Date2022-06-16
PMAP130016
SupplementS049
Product CodePGQ 
Advisory CommitteeEar Nose & Throat
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination ProductNo
Applicant AddressCochlear Americas
13059 East Peakview Avenue
centennial, CO 80111 PMA NumberP130016 Supplement NumberS049 Date Received05/02/2022 Decision Date06/16/2022 Product Code PGQ  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement  
The Center For Devices And Radiological Health (CDRH) Of The Food And Drug Administration (FDA) Has Completed Its Review Of Your Premarket Approval Application (PMA) Supplement, Which Requested Approval Of The Revised Protocol For The Post-approval Study (PAS) Referenced Above (i.e., Change The Study Duration From 5-year Postactivation Follow-up To 3-year Postactiviation Follow-up). The PAS Protocol Has Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P130016 Dated March 20, 2014. Based Upon The Information Submitted, The PMA Supplement Is Approved.

Supplemental Filings

Supplement NumberDateSupplement Type
P130016Original Filing
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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