FDA.reportPublic FDA data

Cobra PzF

Primary DI
00879397000784
Brand
Cobra PzF
Company
CELONOVA BIOSCIENCES, INC.
Model
170-03-30012
Catalog number
170-03-30012
Device description
NanoCoated Coronary Stent System
Published
2017-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAFStent, Coronary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAFStent, CoronaryUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160014000COBRA PzF NanoCoated Coronary Stent SystemCelonova Biosciences, Inc.2017-02-21MAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00879397000784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00879397000784008793970007848793970007840879397000784

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal coronary artery stentA non-bioabsorbable tubular device [bare metal stent (BMS)] intended to be implanted in a coronary artery or saphenous vein graft of the heart to maintain luminal patency and improve luminal diameter typically in a patient with symptomatic atherosclerotic heart disease. It is typically made of high-grade stainless steel or cobalt-chrome (Co-Cr), may be linear or have a bifurcation design (e.g., shaped as a Y in a tube form), and may be balloon-expanded or self-expandable. Dedicated disposable implantation devices (e.g., balloon catheter, delivery instrument) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12Millimeter
Lumen/Inner Diameter3Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
168593429
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00879397000074Embozene Microspheres (Color-Advanced)111010-S12015-07-15
00879397000081Embozene Microspheres (Color-Advanced)111020-S12015-07-15
00879397000098Embozene Microspheres (Color-Advanced)113010-S12015-07-15
00879397000104Embozene Microspheres (Color-Advanced)113020-S12015-07-15
00879397000111Embozene Microspheres (Color-Advanced)10410-S12015-07-15
00879397000128Embozene Microspheres (Color-Advanced)10420-S12015-07-15
00879397000135Embozene Microspheres (Color-Advanced)10710-S12015-07-15
00879397000142Embozene Microspheres (Color-Advanced)10720-S12015-07-15
00879397000241ONCOZENE Microspheres 10420-US12015-07-15
00879397000258ONCOZENE Microspheres10430-US12015-07-15
00879397000265ONCOZENE Microspheres 10720-US12015-07-15
00879397000272ONCOZENE Microspheres 10730-US12015-07-15
00879397000289ONCOZENE Microspheres11020-US12015-07-15
00879397000296ONCOZENE Microspheres11030-US12015-07-15
00879397001118Embozene Microspheres (Color-Advanced)11010-S12015-07-15
00879397001125Embozene Microspheres (Color-Advanced)11020-S12015-07-15
00879397002115Embozene Microspheres (Color-Advanced)12010-S12015-07-15
00879397002122Embozene Microspheres (Color-Advanced)12020-S12015-07-15
00879397003228Embozene Microspheres (Opaque)10410-S02015-07-15
00879397003235Embozene Microspheres (Opaque)10420-S02015-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00894588002125Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002132Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002149Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002156Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002163Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002170Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002187Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
10705032064736PALMAZ Balloon Expandable StentCordis US Corp.MAF2015-05-07
10705032076197PALMAZ Balloon Expandable StentCordis US Corp.MAF2015-05-07
10705032076234PALMAZ Balloon Expandable StentCordis US Corp.MAF2015-05-07
10705032076241PALMAZ Balloon Expandable StentCordis US Corp.MAF2015-05-07
20705032057285PALMAZ Balloon Expandable StentCORDIS CORPORATIONMAF2015-05-07
20705032057261PALMAZ Balloon Expandable StentCORDIS CORPORATIONMAF2015-05-07
20705032057247PALMAZ Balloon Expandable StentCORDIS CORPORATIONMAF2015-05-07
20705032057346PALMAZ Balloon Expandable StentCORDIS CORPORATIONMAF2015-05-07
10705032076227PALMAZ Balloon Expandable StentCordis US Corp.MAF2015-04-29
20705032057223PALMAZ Balloon Expandable StentCORDIS CORPORATIONMAF2015-04-29
08714729203940WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729203957WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729203964WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729203971WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729203988WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729203995WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204008WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204015WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204022WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204039WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204046WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204053WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729406433WALLSTENT™ RP EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24