FDA.reportPublic FDA data

Resolute Onyx™

Primary DI
00643169556942
Brand
Resolute Onyx™
Company
MEDTRONIC, INC.
Model
RONYX27534UX
Device description
STENT RONYX27534UX RESOLUTE ONYX 2.75X34
Published
2017-05-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIQCoronary drug-eluting stent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIQCoronary Drug-Eluting StentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160043000
P160043007
P160043011
P160043031
P160043032
P160043037

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160043000RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMMedtronic Vascular2017-04-28NIQ
P160043007RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMMedtronic Vascular2017-04-28NIQ
P160043011RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMMedtronic Vascular2017-04-28NIQ
P160043031RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMMedtronic Vascular2017-04-28NIQ
P160043032RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMMedtronic Vascular2017-04-28NIQ
P160043037RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMMedtronic Vascular2017-04-28NIQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169556942PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169556942006431695569426431695569420643169556942

GMDN Terms#

Term, Definition table
TermDefinition
Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coatedA sterile non-bioabsorbable metal tubular mesh structure covered with a non-bioabsorbable polymer and a drug coating that is designed to be implanted, via a delivery catheter, into a coronary artery (or saphenous vein graft) to maintain its patency typically in a patient with symptomatic atherosclerotic heart disease. The drug coating is slowly released and intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length34Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
1
Combination product
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07290107017961EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017978EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
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08717648231308XIENCE Skypoint™ABBOTT VASCULAR INC.NIQ2023-12-15
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07290107015202EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015219EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015226EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015233EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015240EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015257EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015264EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015271EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015288EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015295EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015301EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015318EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015325EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015332EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015349EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015356EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015363EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10