Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008301917

FEI Number

3008301917

Entity Name

INTERSECT ENT

City/State/Country

Menlo Park, CA, US

Establishment Address

1555 Adams Dr, Menlo Park, CA 94025, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Medtronic, Inc. (Owner Number: 2112641)

Owner / Operator Contact Address

710 Medtronic Parkway, Minneapolis, MN 55432, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P100044

All Registered Proprietary Names

Propel Contour Sinus Implant Propel Sinus Implant Propel Mini Sinus Implant with Straight Deliver System (SDS) Propel Mini Sinus Implant

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OWO	Drug-Eluting Sinus Stent	Unknown	Class 3	N/A	2022-11-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medtronic, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007042319	HeartWare, Inc.	Miami Lakes, FL, US
3004497303	MEDTRONIC MEXICO EG	EMPALME Sonora, MX
3015192387	CATHWORKS	Newport Beach, CA, US
3004185781	Medtronic, Inc.	Tempe, AZ, US
3012520654	MEDTRONIC, INC.	Billerica, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103464	Medtronic, Inc.	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	2010-12-22
K111339	Medtronic, Inc.	HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)	2011-06-08

Similar Registrations

Registration Number	Establishment Name	Location
3012102437	Synergy Health AST, LLC	Petaluma, CA, US
3012448339	STERI-TEK	Fremont, CA, US
3031365458	WOMED SAS	Montpellier Herault, FR
3009999323	STORE-ALL LOGISTICS LTD	Slieverue Kilkenny, IE
3008478369	FERROSAN MEDICAL DEVICES A/S	Soeborg Hovedstaden, DK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008301917. Last updated year: 2026. Please use registration number 3008301917 when referencing this establishment in official correspondence.