Propel Mini Sinus Implant

FDA Premarket Approval P100044 S046

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

The current supplement requested approval for a new packaging configuration and labeling changes for the propel mini sinus implant.

DevicePropel Mini Sinus Implant
Generic NameDrug-eluting Sinus Stent
ApplicantINTERSECT ENT
Date Received2020-04-02
Decision Date2020-07-01
PMAP100044
SupplementS046
Product CodeOWO 
Advisory CommitteeEar Nose & Throat
Supplement TypeReal-time Process
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
S046 2020-04-02 Real-time Process
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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