Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C

FDA Premarket Approval P100044 S050

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

DevicePropel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C
Generic NameDrug-eluting Sinus Stent
ApplicantINTERSECT ENT1555 Adams Drmenlo Park, CA 94025 PMA NumberP100044 Supplement NumberS050 Date Received10/05/2022 Decision Date11/04/2022 Product Code OWO  Advisory Committee Ear Nose & Throat Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-05
Decision Date2022-11-04
PMAP100044
SupplementS050
Product CodeOWO 
Advisory CommitteeEar Nose & Throat
Supplement TypeSpecial (immediate Track)
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductYes
Applicant AddressINTERSECT ENT
1555 Adams Dr
menlo Park, CA 94025 PMA NumberP100044 Supplement NumberS050 Date Received10/05/2022 Decision Date11/04/2022 Product Code OWO  Advisory Committee Ear Nose & Throat Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement  
Approval For An Additional Control To Ensure The Spray Coaters Are Running Optimally During The Manufacturing Process.

Supplemental Filings

Supplement NumberDateSupplement Type
P100044Original Filing
S050 2022-10-05 Special (immediate Track)
S049 2022-03-28 Real-time Process
S048 2021-01-11 Real-time Process
S047
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

NIH GUDID Devices

Device IDPMASupp
M927700110 P100044 000
M927600110 P100044 001
M927500110 P100044 023
M927600440 P100044 046

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