Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)

FDA Premarket Approval P150004 S056

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

DeviceDorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)
Generic NameDorsal Root Ganglion Stimulator For Pain Relief
ApplicantAbbott Medical6901 Preston Roadplano, TX 75024 PMA NumberP150004 Supplement NumberS056 Date Received02/22/2022 Decision Date03/24/2022 Product Code PMP  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
PMAP150004
SupplementS056
Product CodePMP 
Advisory CommitteeNeurology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressAbbott Medical
6901 Preston Road
plano, TX 75024 PMA NumberP150004 Supplement NumberS056 Date Received02/22/2022 Decision Date03/24/2022 Product Code PMP  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
P150004Original Filing
S057 2022-05-23 Real-time Process
S056 2022-02-22 30-day Notice
S055 2022-01-18 30-day Notice
S054 2021-10-22 Real-time Process
S053
S052
S051 2021-07-07 Normal 180 Day Track No User Fee
S050 2021-07-01 30-day Notice
S049
S048 2021-06-15 Special (immediate Track)
S047 2021-05-10 30-day Notice
S046 2021-03-25 30-day Notice
S045
S044
S043 2020-09-09 Normal 180 Day Track
S042 2020-07-27 Real-time Process
S041
S040
S039 2020-05-07 30-day Notice
S038 2020-04-30 30-day Notice
S037
S036 2020-04-06 30-day Notice
S035 2020-04-06 30-day Notice
S034 2019-12-13 30-day Notice
S033
S032 2019-10-21 30-day Notice
S031 2019-07-01 30-day Notice
S030 2019-05-02 Real-time Process
S029
S028 2018-11-08 30-day Notice
S027 2018-09-28 Real-time Process
S026 2018-09-04 Real-time Process
S025 2018-08-20 30-day Notice
S024 2018-06-18 Real-time Process
S023 2018-05-30 Normal 180 Day Track No User Fee
S022 2018-04-20 30-day Notice
S021
S020 2018-02-13 Normal 180 Day Track
S019 2017-12-18 30-day Notice
S018 2017-11-16 30-day Notice
S017 2017-11-15 30-day Notice
S016 2017-11-09 30-day Notice
S015 2017-09-13 30-day Notice
S014 2017-09-11 Real-time Process
S013 2017-08-22 30-day Notice
S012 2017-08-10 30-day Notice
S011
S010 2017-06-02 30-day Notice
S009 2017-04-06 30-day Notice
S008 2017-04-03 Normal 180 Day Track
S007 2017-02-14 Normal 180 Day Track No User Fee
S006 2016-11-07 Normal 180 Day Track
S005 2016-10-05 Normal 180 Day Track No User Fee
S004 2016-07-21 30-day Notice
S003
S002 2016-06-06 Normal 180 Day Track
S001 2016-03-11 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
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05415067027122 P150004 008
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05415067029072 P150004 008

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