Propel Family of Sinus Implants

FDA Premarket Approval P100044 S045

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 modifications to the instructions for use (ifu) to enhance the safe use of the propel family of implants (propel, propel mini and propel contour).

DevicePropel Family of Sinus Implants
Generic NameDrug-eluting Sinus Stent
ApplicantINTERSECT ENT
Date Received2020-03-26
Decision Date2020-04-24
PMAP100044
SupplementS045
Product CodeOWO 
Advisory CommitteeEar Nose & Throat
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product Yes
Applicant Address INTERSECT ENT 1555 Adams Dr menlo Park, CA 94025

Supplemental Filings

Supplement NumberDateSupplement Type
P100044Original Filing
S045 2020-03-26 Special (immediate Track)
S044 2019-09-10 30-day Notice
S043
S042 2019-05-31 30-day Notice
S041 2019-05-03 30-day Notice
S040 2019-05-01 30-day Notice
S039 2019-04-26 30-day Notice
S038
S037 2018-11-30 Real-time Process
S036 2018-10-12 Real-time Process
S035 2018-08-24 30-day Notice
S034 2018-08-08 30-day Notice
S033 2018-06-08 30-day Notice
S032 2018-05-02 30-day Notice
S031 2017-09-08 Special (immediate Track)
S030 2017-08-29 30-day Notice
S029 2017-05-30 30-day Notice
S028 2017-04-27 30-day Notice
S027 2017-03-01 Real-time Process
S026 2016-12-27 30-day Notice
S025 2016-09-30 30-day Notice
S024 2016-09-28 30-day Notice
S023 2016-08-01 Panel Track
S022 2016-06-16 135 Review Track For 30-day Notice
S021 2016-05-18 30-day Notice
S020 2016-03-25 Normal 180 Day Track No User Fee
S019 2015-09-30 30-day Notice
S018 2015-09-25 Panel Track
S017 2015-04-02 Normal 180 Day Track No User Fee
S016 2014-04-23 30-day Notice
S015 2014-01-16 30-day Notice
S014 2013-11-12 30-day Notice
S013 2013-11-04 Real-time Process
S012 2013-09-30 Normal 180 Day Track No User Fee
S011 2013-08-21 30-day Notice
S010 2013-06-25 Special (immediate Track)
S009
S008 2013-03-04 Normal 180 Day Track No User Fee
S007 2013-01-29 30-day Notice
S006 2012-12-26 Normal 180 Day Track No User Fee
S005 2012-12-20 30-day Notice
S004 2012-12-14 Normal 180 Day Track No User Fee
S003 2012-10-01 Real-time Process
S002 2012-07-31 30-day Notice
S001 2012-03-12 Normal 180 Day Track

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