FDA.reportPublic FDA data

Harmony™

Primary DI
00763000341367
Brand
Harmony™
Company
MEDTRONIC, INC.
Model
HARMONY-DCS
Device description
"HARMONY"" DELIVERY CATHETER SYSTEM"
Published
2021-04-22
Public version status
New
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
NPVPulmonary valve prosthesis percutaneously delivered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPVPulmonary Valve Prosthesis Percutaneously DeliveredUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P200046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200046000Harmony™ TPV SystemMedtronic, Inc.2021-03-26NPV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000341367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000341367007630003413677630003413670763000341367

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary transcatheter heart valve bioprosthesisAn implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed or regurgitant pulmonary heart valve prosthesis (previously implanted), or native pulmonary valve anatomy that may have been surgically repaired, and which is designed to be implanted with a catheter via vascular access. It may be attached to an expandable metal framework which may be expanded with a balloon or self-expand, and may include other material types (e.g., synthetic polymer). Devices associated with implantation (e.g., catheter, introducer) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length101Centimeter
Outer Diameter8.33Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Store the DCS at room temperature and away from direct sunlight

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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00824846005445NA12T76R12026-07-30
00824846005469NABB2Q31R112026-07-30
00824846005667NABB9R33R162026-07-30
00824846006022NABB12S36R2026-07-30
00824846007944NABB12W03R12026-07-30
00613994746627ATTAIN SELECT™ II624890D022016-07-16
00763000862336MyCareLink™249552026-07-26
00763000060374LINQ II™LNQ222020-07-18
00763000422615SYNCHROMED®II8637-402021-04-11
00763000634094SYNCHROMED® II8637-202022-08-11
00763000634100SYNCHROMED® II8637-402022-08-11
00643169508149SYNCHROMED® II8637-202016-04-27
00643169508156SYNCHROMED® II8637-402016-04-27
00643169630505SYNCHROMED® II8637-202018-08-17
00643169630512SYNCHROMED® II8637-402018-08-17
00643169100824SYNCHROMED ® II8637-402016-04-27
00643169100831SYNCHROMED ® II8637-202016-04-27
00199150084036MiniMed Flex Starter KitMMT-8076B2026-07-19
00199150084043MiniMed Flex Starter KitMMT-8076C2026-07-19
00199150084050MiniMed Extended Supply KitMMT-445B2026-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00690103221312Edwards SAPIEN 3 transcatheter pulmonic valve delivery systemEdwards Lifesciences LLCNPV2026-02-17
00690103221329Edwards SAPIEN 3 transcatheter pulmonic valve delivery systemEdwards Lifesciences LLCNPV2026-02-17
00690103221336Edwards SAPIEN 3 transcatheter pulmonic valve delivery systemEdwards Lifesciences LLCNPV2026-02-17
00690103221343Edwards SAPIEN 3 transcatheter pulmonic valve delivery systemEdwards Lifesciences LLCNPV2026-02-17
00690103210873EDWARDS SAPIEN 3 PULMONIC DELIVERY SYSTEM (29MM)Edwards Lifesciences LLCNPV2022-01-04
00690103210866THE EDWARDS SAPIEN 3 VALVE WITH ALTERRA ADAPTIVE PRESTENT SYSTEMEdwards Lifesciences LLCNPV2021-12-23
00763000338985Harmony™MEDTRONIC, INC.NPV2021-04-22
00763000338992Harmony™MEDTRONIC, INC.NPV2021-04-22
00643169713888Ensemble™ llMEDTRONIC, INC.NPV2016-10-31
00643169713895Ensemble™ llMEDTRONIC, INC.NPV2016-10-31
00643169713901Ensemble™ llMEDTRONIC, INC.NPV2016-10-31
00690103193930EDWARDS COMMANDER DELIVERY SYSTEMEdwards Lifesciences LLCNPV2015-07-05
00690103193947EDWARDS COMMANDER DELIVERY SYSTEMEdwards Lifesciences LLCNPV2015-07-05
00690103193954EDWARDS COMMANDER DELIVERY SYSTEMEdwards Lifesciences LLCNPV2015-07-05
00690103193961EDWARDS COMMANDER DELIVERY SYSTEMEdwards Lifesciences LLCNPV2015-07-05
00690103194005EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)Edwards Lifesciences LLCNPV2015-07-05
00690103194340EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)Edwards Lifesciences LLCNPV2015-07-05
00690103194357EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)Edwards Lifesciences LLCNPV2015-07-05
00690103194364EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)Edwards Lifesciences LLCNPV2015-07-05
00643169588189Melody™ TPVMEDTRONIC, INC.NPV2015-02-24
00643169588196Melody™ TPVMEDTRONIC, INC.NPV2015-02-24
00643169588431Ensemble™MEDTRONIC, INC.NPV2015-02-24
00643169588448Ensemble™MEDTRONIC, INC.NPV2015-02-24
00643169588455Ensemble™MEDTRONIC, INC.NPV2015-02-24
00643169298569Contegra®MEDTRONIC, INC.NPV2014-09-23
00643169415720ENSEMBLE™MEDTRONIC, INC.NPV2014-09-23
00643169415744ENSEMBLE™MEDTRONIC, INC.NPV2014-09-23
00643169415768ENSEMBLE™MEDTRONIC, INC.NPV2014-09-23
00643169415850Melody™ TPVMEDTRONIC, INC.NPV2014-09-23
00643169415874Melody™ TPVMEDTRONIC, INC.NPV2014-09-23