FDA.reportPublic FDA data

SYNERGY MEGATRON™

Primary DI
08714729985679
Brand
SYNERGY MEGATRON™
Company
BOSTON SCIENTIFIC CORPORATION
Model
H7493942820450
Device description
Everolimus-Eluting Platinum Chromium Coronary Stent System
Published
2021-01-26
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
NIQCoronary drug-eluting stent

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150003054
P150003088
P150003090
P150003096
P150003099
P150003102
P150003105

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150003054SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMBoston Scientific Corporation2015-10-02NIQ
P150003088SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMBoston Scientific Corporation2015-10-02NIQ
P150003090SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMBoston Scientific Corporation2015-10-02NIQ
P150003096SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMBoston Scientific Corporation2015-10-02NIQ
P150003099SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMBoston Scientific Corporation2015-10-02NIQ
P150003102SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMBoston Scientific Corporation2015-10-02NIQ
P150003105SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMBoston Scientific Corporation2015-10-02NIQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729985679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729985679087147299856798714729985679

GMDN Terms#

Term, Definition table
TermDefinition
Drug-eluting coronary artery stent, bioabsorbable-polymer-coatedA sterile non-bioabsorbable metal tubular mesh structure covered with a bioabsorbable polymer that contains a drug, 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 is slowly released as the polymer degrades and is intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation. Some types may be dedicated to implantation across a coronary artery bifurcation. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Stent Diameter4.5Millimeter
Stent Length20Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506049232Orbera™M00505670M005056702026-06-04
08714729121190Ultraflex™ Esophageal NGM005142002015-09-24
08714729121206Ultraflex™ Esophageal NGM005142102015-09-24
08714729121213Ultraflex™ Esophageal NGM005142202015-09-24
08714729121220Ultraflex™ Esophageal NGM005142302015-09-24
08714729649113Ultraflex™ Esophageal NGM005137502015-09-24
08714729716075Ultraflex™ Esophageal NGM005138502015-09-24
08714729716082Ultraflex™ Esophageal NGM005138602015-09-24
08714729716099Ultraflex™ Esophageal NGM005138402015-09-24
08714729716105Ultraflex™ Esophageal NGM005142402015-09-24
08714729716112Ultraflex™ Esophageal NGM005142502015-09-24
08714729716129Ultraflex™ Esophageal NGM005137002015-09-24
08714729716136Ultraflex™ Esophageal NGM005137102015-09-24
08714729716143Ultraflex™ Esophageal NGM005137202015-09-24
08714729716150Ultraflex™ Esophageal NGM005137302015-09-24
08714729716167Ultraflex™ Esophageal NGM005137402015-09-24
08714729716174Ultraflex™ Esophageal NGM005138002015-09-24
08714729716181Ultraflex™ Esophageal NGM005138102015-09-24
08714729716198Ultraflex™ Esophageal NGM005138202015-09-24
08714729716204Ultraflex™ Esophageal NGM005138302015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290107017930EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017947EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017954EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017961EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017978EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017985EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017992EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107018005EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
08717648231261XIENCE Skypoint™ABBOTT VASCULAR INC.NIQ2023-12-15
08717648231278XIENCE Skypoint™ABBOTT VASCULAR INC.NIQ2023-12-15
08717648231285XIENCE Skypoint™ABBOTT VASCULAR INC.NIQ2023-12-15
08717648231308XIENCE Skypoint™ABBOTT VASCULAR INC.NIQ2023-12-15
08717648231315XIENCE Skypoint™ABBOTT VASCULAR INC.NIQ2023-12-15
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