Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)

FDA Premarket Approval P140009 S076

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

DeviceInfinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
Generic NameStimulator, Electrical, Implanted, For Parkinsonian Tremor
ApplicantAbbott Medical6901 Prestion Roadplano, TX 75024 PMA NumberP140009 Supplement NumberS076 Date Received02/22/2022 Decision Date03/24/2022 Product Codes PJS MHY NHL  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-02-22
Decision Date2022-03-24
PMAP140009
SupplementS076
Advisory CommitteeNeurology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressAbbott Medical
6901 Prestion Road
plano, TX 75024 PMA NumberP140009 Supplement NumberS076 Date Received02/22/2022 Decision Date03/24/2022 Product Codes PJS MHY NHL  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
an Update To The Post-Header Test System Non-Product Software Used During Assembly Of Orion Family (Proclaim SCS, Infinity DBS, Proclaim DRG) Implantable Pulse Generators (IPGs)

Supplemental Filings

Supplement NumberDateSupplement Type
P140009Original Filing
S080 2022-09-29 30-day Notice
S079 2022-09-21 30-day Notice
S078 2022-06-02 30-day Notice
S077
S076 2022-02-22 30-day Notice
S075 2022-01-18 30-day Notice
S074 2021-10-22 Real-time Process
S073
S072 2021-07-01 30-day Notice
S071
S070 2021-06-15 Special (immediate Track)
S069 2021-05-10 30-day Notice
S068 2021-03-25 30-day Notice
S067
S066 2021-02-08 30-day Notice
S065 2020-10-28 135 Review Track For 30-day Notice
S064 2020-09-09 Normal 180 Day Track
S063 2020-07-27 Real-time Process
S062
S061 2020-07-13 Special (immediate Track)
S060 2020-05-07 30-day Notice
S059 2020-04-30 30-day Notice
S058
S057 2020-04-06 30-day Notice
S056 2020-04-06 30-day Notice
S055 2020-02-03 30-day Notice
S054 2019-12-13 30-day Notice
S053
S052
S051 2019-10-21 30-day Notice
S050 2019-08-09 Special (immediate Track)
S049
S048 2019-07-01 30-day Notice
S047 2019-05-07 Normal 180 Day Track No User Fee
S046
S045 2019-02-01 30-day Notice
S044 2018-12-17 30-day Notice
S043 2018-11-08 30-day Notice
S042 2018-10-19 30-day Notice
S041 2018-10-18 Special (immediate Track)
S040 2018-09-06 30-day Notice
S039
S038 2018-05-04 135 Review Track For 30-day Notice
S037 2018-02-13 Normal 180 Day Track
S036 2018-02-02 135 Review Track For 30-day Notice
S035 2017-12-18 30-day Notice
S034 2017-12-15 Real-time Process
S033 2017-12-15 30-day Notice
S032 2017-11-16 30-day Notice
S031 2017-11-13 30-day Notice
S030 2017-09-11 Real-time Process
S029 2017-09-08 30-day Notice
S028 2017-08-10 30-day Notice
S027 2017-07-28 Normal 180 Day Track No User Fee
S026
S025 2017-06-26 30-day Notice
S024 2017-06-02 30-day Notice
S023 2017-02-14 Real-time Process
S022 2016-11-07 Normal 180 Day Track
S021 2016-11-01 30-day Notice
S020 2016-10-11 Real-time Process
S019 2016-07-11 Real-time Process
S018
S017 2016-06-22 Real-time Process
S016 2016-06-13 30-day Notice
S015 2016-06-06 Normal 180 Day Track
S014 2016-04-28 30-day Notice
S013 2016-03-21 30-day Notice
S012 2016-02-02 30-day Notice
S011 2016-01-27 30-day Notice
S010 2015-12-11 Normal 180 Day Track
S009 2015-11-09 30-day Notice
S008 2015-11-06 30-day Notice
S007 2015-10-08 30-day Notice
S006 2015-10-07 30-day Notice
S005 2015-09-21 Real-time Process
S004 2015-08-21 Normal 180 Day Track No User Fee
S003 2015-08-14 30-day Notice
S002 2015-08-04 Real-time Process
S001 2015-07-02 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
05415067020697 P140009 001
05415067020673 P140009 001
05415067020680 P140009 001
05415067020659 P140009 001
05415067020703 P140009 001
05415067020857 P140009 001
05415067020864 P140009 001
05415067023667 P140009 001
05415067023988 P140009 001
05415067024015 P140009 001
05415067020642 P140009 001
05415067020635 P140009 001
05415067020307 P140009 001
05415067020277 P140009 001
05415067020260 P140009 001
05415067020253 P140009 001
05415067020246 P140009 001
05415067020666 P140009 001
05415067030351 P140009 037
05415067030344 P140009 037
05415067030337 P140009 037
05415067030320 P140009 037
05415067030313 P140009 037
05415067030306 P140009 037
05415067030023 P140009 037
05415067030016 P140009 037
05415067047670 P140009 087
05415067047663 P140009 087

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