Lutonix 018 and 035 Drug Coated Balloon

FDA Premarket Approval P130024 S040

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

Revised release specifications for related substances

DeviceLutonix 018 and 035 Drug Coated Balloon
Generic NameDrug-eluting Peripheral Transluminal Angioplasty Catheter
Date Received2021-03-08
Decision Date2021-06-03
Product CodeONU 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address LUTONIX 9409 Science Center Dr new Hope, MN 55428

Supplemental Filings

Supplement NumberDateSupplement Type
P130024Original Filing
S040 2021-03-08 Real-time Process
S037 2020-09-30 Real-time Process
S036 2020-04-13 30-day Notice
S033 2019-11-29 Real-time Process
S032 2019-11-25 30-day Notice
S030 2019-09-20 Normal 180 Day Track
S029 2019-09-03 Special (immediate Track)
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
S018 2017-02-06 30-day Notice
S017 2016-11-28 30-day Notice
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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