LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

Drug-eluting Peripheral Transluminal Angioplasty Catheter

FDA Premarket Approval P130024 S008

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 changes to the instructions for use to provide details regarding the use of bare metal stents with the device for bailout stenting.

DeviceLUTONIX 035 DRUG COATED BALLOON PTA CATHETER
Classification NameDrug-eluting Peripheral Transluminal Angioplasty Catheter
Generic NameDrug-eluting Peripheral Transluminal Angioplasty Catheter
ApplicantLUTONIX
Date Received2015-11-09
Decision Date2015-11-24
PMAP130024
SupplementS008
Product CodeONU
Advisory CommitteeCardiovascular
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product Yes
Applicant Address LUTONIX 9409 Science Center Dr new Hope, MN 55428

Supplemental Filings

Supplement NumberDateSupplement Type
P130024Original Filing
S042 2021-11-18 30-day Notice
S041 2021-07-06 30-day Notice
S040 2021-03-08 Real-time Process
S039
S038
S037 2020-09-30 Real-time Process
S036 2020-04-13 30-day Notice
S035
S034
S033 2019-11-29 Real-time Process
S032 2019-11-25 30-day Notice
S031
S030 2019-09-20 Normal 180 Day Track
S029 2019-09-03 Special (immediate Track)
S028
S027 2019-02-26 Real-time Process
S026 2018-11-16 Real-time Process
S025 2018-10-04 Real-time Process
S024 2018-06-25 Real-time Process
S023 2018-06-20 30-day Notice
S022 2018-01-25 Normal 180 Day Track
S021 2017-12-08 Normal 180 Day Track No User Fee
S020 2017-09-25 Normal 180 Day Track No User Fee
S019
S018 2017-02-06 30-day Notice
S017 2016-11-28 30-day Notice
S016
S015 2016-08-15 Normal 180 Day Track No User Fee
S014 2016-07-05 Normal 180 Day Track
S013 2016-06-15 Normal 180 Day Track No User Fee
S012 2016-04-29 Special (immediate Track)
S011 2016-03-25 Normal 180 Day Track No User Fee
S010 2016-01-27 Real-time Process
S009 2016-01-04 Panel Track
S008 2015-11-09 Special (immediate Track)
S007 2015-08-07 Special (immediate Track)
S006 2015-07-13 Normal 180 Day Track No User Fee
S005 2015-06-02 Normal 180 Day Track
S004 2015-03-02 Real-time Process
S003 2015-02-25 135 Review Track For 30-day Notice
S002 2015-01-12 Normal 180 Day Track
S001 2014-11-24 Real-time Process

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