FDA.reportPublic FDA data

PROPEL

Primary DI
00763000710330
Brand
PROPEL
Company
MEDTRONIC XOMED, INC.
Model
60011
Device description
IMPLANT 60011 PROPEL MINI
Published
2023-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWODrug-eluting sinus stent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWODrug-Eluting Sinus StentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P100044018

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100044018PROPELIntersect Ent.2011-08-11OWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000710365PackageGS15In Commercial Distribution
00763000710330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300071036520763000710365
00763000710330007630007103307630007103300763000710330

GMDN Terms#

Term, Definition table
TermDefinition
Drug-eluting paranasal sinus stentA bioabsorbable device with a drug coating intended to be implanted into a paranasal sinus (e.g., frontal, sphenoidal, ethmoidal, maxillary) to maintain sinus patency in the treatment of chronic sinusitis. The drug coating is intended to reduce inflammation and polyps to facilitate the separation of sinus mucosal tissues. The device is made of synthetic polymer(s) capable of being degraded and absorbed by body tissues, and is designed to allow for the slow release of the drug coating. It is endoscopically implanted via the nasal passageway; disposable devices associated with implantation may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835465063
Device count
1
Combination product
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000821777NIM EssenceNIMEID0602026-06-07
00763000821784NIM EssenceNIMEID0652026-06-07
00763000821791NIM EssenceNIMEID0702026-06-07
00763000821807NIM EssenceNIMEID0752026-06-07
00763000821814NIM EssenceNIMEID0802026-06-07
00199150064069ApexCut187BL40002026-04-25
00199150064076ApexCut187BL4000L2026-04-25
00199150064083ApexCut187BL40122026-04-25
00199150064090ApexCut187BL40402026-04-25
00199150064106ApexCut187BL40602026-04-25
00763000945640ApexCut187BL29002026-04-25
00763000945657ApexCut187BL35002026-04-25
00763000945718ApexCut187BL35122026-04-25
00763000945732ApexCut187BL35402026-04-25
00763000945756ApexCut187BL29602026-04-24
00763000945763ApexCut187BL35602026-04-25
00763000945787ApexCut187BL29752026-04-25
00763000945794ApexCut187BL35902026-04-25
00763000945800ApexCut187BL351202026-04-25
20643169782666NIM Trivantage®82297392016-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000710279PROPELMEDTRONIC XOMED, INC.OWO2023-07-08
00763000710392PROPELMEDTRONIC XOMED, INC.OWO2023-07-08
00763000710453PROPELMEDTRONIC XOMED, INC.OWO2023-07-08
20763000710303PROPELMEDTRONIC XOMED, INC.OWO2023-07-08
20763000710365PROPELMEDTRONIC XOMED, INC.OWO2023-07-08
20763000710426PROPELMEDTRONIC XOMED, INC.OWO2023-07-08
20763000710464PROPELMEDTRONIC XOMED, INC.OWO2023-07-08
M927600440PROPEL Mini Sinus Implant with Straight Delivery SystemIntersect Ent, Inc.OWO2020-10-26
M92710061Propel Mini Straight Delivery System (SDS) Single UnitIntersect Ent, Inc.OWO2019-07-30
M927500110Propel ContourIntersect Ent, Inc.OWO2017-02-27
M927700110PropelIntersect Ent, Inc.OWO2014-07-29
M927600110Propel MiniIntersect Ent, Inc.OWO2014-07-29