DRG Small/Big Curve Delivery Sheath Kit, 22cm; DRG Lead Accessories Kit; SlimTip DRG Trial Lead Kit, 50cm and 90cm; Slim

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Premarket Approval P150004 S024

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 alternative ink for the pad printed marker bands on the drg delivery sheaths.

DeviceDRG Small/Big Curve Delivery Sheath Kit, 22cm; DRG Lead Accessories Kit; SlimTip DRG Trial Lead Kit, 50cm and 90cm; Slim
Classification NameDorsal Root Ganglion Stimulator For Pain Relief
Generic NameDorsal Root Ganglion Stimulator For Pain Relief
ApplicantAbbott Medical
Date Received2018-06-18
Decision Date2018-09-14
PMAP150004
SupplementS024
Product CodePMP
Advisory CommitteeNeurology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Medical 6901 Preston Road plano, TX 75024

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
05415067025678 P150004 000
05415067025593 P150004 000
05415067025609 P150004 000
05415067025616 P150004 000
05415067025623 P150004 000
05415067025630 P150004 000
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05415067025654 P150004 000
05415067025708 P150004 000
05415067025586 P150004 000
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05415067025531 P150004 000
05415067025548 P150004 000
05415067025555 P150004 000
05415067025562 P150004 000
05415067025661 P150004 000
05415067020215 P150004 002
15415067026993 P150004 002
05415067027344 P150004 002
05415067027337 P150004 002
05415067027313 P150004 002
05415067027184 P150004 002
05415067027214 P150004 005
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05415067027160 P150004 005
05415067027153 P150004 005
05415067027146 P150004 005
05415067027139 P150004 005
05415067027122 P150004 008
05415067027863 P150004 008
05415067029072 P150004 008

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