Intersect Ent

FDA Filings

This page includes the latest FDA filings for Intersect Ent. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3008301917
• FEI Number: 3008301917
• Name: INTERSECT ENT
• Owner & Operator: Intersect ENT
• Contact Address: 1555 Adams Drive ; Menlo Park CA 94025 US
• Official Correspondent:
  • Amy Conuel Wolbeck
  • x-650-6412115-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1555 Adams Dr ; Menlo Park, CA 94025 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K212774 Intersect ENT	VenSure LightGuide	2022-02-04
PMA P100044S048 INTERSECT ENT	Propel and Propel Mini Sinus Implants	2021-04-09
PMA P100044S046 INTERSECT ENT	Propel Mini Sinus Implant	2020-07-01
PMA P100044S045 INTERSECT ENT	Propel Family of Sinus Implants	2020-04-24
PMA P100044S044 INTERSECT ENT	Propel, Propel Mini and Propel Contour (Propel Familly) Sinus Implants	2019-10-08
PMA P100044S042 INTERSECT ENT	Propel, Propel Mini and Propel Contour Sinus Implants	2019-06-27
PMA P100044S041 INTERSECT ENT	Propel Contour Sinus Implant	2019-05-31
PMA P100044S040 INTERSECT ENT	Propel Contour Sinus Implant	2019-05-31
PMA P100044S039 INTERSECT ENT	Propel, Propel Mini and Propel Contour Sinus Implants	2019-05-23
PMA P100044S037 INTERSECT ENT	Propel Contour Sinus Implant	2019-02-28
PMA P100044S036 INTERSECT ENT	Propel Family of Sinus Implants	2019-01-10
PMA P100044S035 INTERSECT ENT	Propel Sinus Implant, Propel Mini Sinus Implant, Propel Contour Sinus Implant	2018-09-21
PMA P100044S034 INTERSECT ENT	Propel and Propel Mini Sinus Implants	2018-09-07
PMA P100044S033 INTERSECT ENT	Propel Contour Sinus Implant	2018-06-28
PMA P100044S032 INTERSECT ENT	Propel, Propel mini and Propel Contour Sinus Implants	2018-06-01
PMA P100044S031 INTERSECT ENT	PROPEL Contour SInus Implant	2017-10-13
PMA P100044S030 INTERSECT ENT	Mometasone Furoate Container Closure System	2017-09-27
PMA P100044S022 INTERSECT ENT	PROPEL AND PROPEL MINI SINUS IMPLANT	2017-07-25
PMA P100044S029 INTERSECT ENT	PROPEL Contour Sinus Implant Delivery System	2017-06-28
PMA P100044S027 INTERSECT ENT	Propel Sinus Implant & Propel mini Sinus Implant	2017-05-30
PMA P100044S028 INTERSECT ENT	Intersect ENT Propel Contour Sinus Implant Component Verification System Generation II	2017-05-24
PMA P100044S023 INTERSECT ENT	PROPEL CONTOUR SINUS IMPLANT	2017-02-23
PMA P100044S026 INTERSECT ENT	PROPEL SINUS IMPLANT & PROPEL MINI SINUS IMPLANT	2017-01-27
PMA P100044S025 INTERSECT ENT	PROPEL SINUS, MINI SINUS IMPLANT.	2016-10-28
PMA P100044S024 INTERSECT ENT	PROPEL, PROPEL MINI SINUS IMPLANT	2016-10-28
PMA P100044S020 INTERSECT ENT	PROPEL	2016-08-24
PMA P100044S021 INTERSECT ENT	PROPEL AND PROPEL MINI SINUS IMPLANTS	2016-06-17
PMA P100044S018 INTERSECT ENT	PROPEL MINI SINUS IMPLANT	2016-03-23
PMA P100044S019 INTERSECT ENT	PROPEL AND PROPEL MINI SINUS IMPLANTS	2015-10-28
PMA P100044S017 INTERSECT ENT	PROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT	2015-05-07
PMA P100044S016 INTERSECT ENT	PROPEL SINUS IMPLANT AND PROPEL MINI SINUS IMPLANT	2014-05-23
PMA P100044S015 INTERSECT ENT	PROPEL AND PROPEL MINI SINUS IMPLANTS	2014-02-11
PMA P100044S012 INTERSECT ENT	INTERSECT ENT PROPEL MINI SINUS IMPLANT	2014-01-31
PMA P100044S013 INTERSECT ENT	PROPEL MINI SINUS IMPLANT	2014-01-09
PMA P100044S014 INTERSECT ENT	PROPEL AND PROPEL MINI SINUS IMPLANTS	2013-12-06
PMA P100044S011 INTERSECT ENT	PROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT	2013-09-18
PMA P100044S010 INTERSECT ENT	PROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT	2013-08-13
PMA P100044S008 INTERSECT ENT	INTERSECTENT PROPEL MINI SINUS IMPLANT	2013-07-17
PMA P100044S006 INTERSECT ENT	PROPEL MINI SINUS IMPLANTS	2013-06-10
PMA P100044S004 INTERSECT ENT	PROPEL SINUS IMPLANT	2013-05-22
PMA P100044S007 INTERSECT ENT	PROPEL AND PROPEL MINI SINUS IMPLANT	2013-02-27
PMA P100044S005 INTERSECT ENT	PROPEL MINI SINUS IMPLANT	2013-01-17
PMA P100044S003 INTERSECT ENT	PROPEL MINI SINUS IMPLANT, 6011	2012-11-09
PMA P100044S001 INTERSECT ENT	PROPEL MINI SINUS IMPLANT	2012-09-21
PMA P100044S002 INTERSECT ENT	PROPEL SINUS IMPLANT	2012-08-10
PMN P100044 | OWO INTERSECT ENT	Propel Sinus Implant	2011-09-02
PMN P100044 | OWO INTERSECT ENT	Propel Mini Straight Delivery System (SDS)	2011-09-02
PMN P100044 | OWO INTERSECT ENT	Propel Mini Sinus Implant	2011-09-02
PMN P100044 | OWO INTERSECT ENT	Propel Contour Sinus Implant	2011-09-02
PMA P100044 INTERSECT ENT	PROPEL	2011-08-11

Similar & Related FDA Registered Companies

• INTERSECT ENT1555 Adams Drmenlo Park, CA 94025 PMA NumberP100044 Supplement NumberS051 Date Received11/25/2022 Decision Date12/22/2022 Product Code OWO  Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• INTERSECT 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
• INTERSECT ENT1555 Adams Drmenlo Park, CA 94025 PMA NumberP100044 Supplement NumberS049 Date Received03/28/2022 Decision Date06/24/2022 Product Code OWO  Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Intersect ENT, INC.
• Intersect ENT GmbH