FDA.reportPublic FDA data

ENSEMBLE™

Primary DI
00643169415768
Brand
ENSEMBLE™
Company
MEDTRONIC, INC.
Model
NU1022
Device description
DELIV SYS NU1022 ENSEMBLE HDE
Published
2014-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
H080002023

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H080002023

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169415768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169415768006431694157686431694157680643169415768

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary transcatheter heart valve bioprosthesisA sterile 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
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from 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
00763000923594HeartWare™ Monitor1521MCS2026-09-25
00763000923709Power CordMCS1621PC2026-09-25
00763000923792Monitor Power CordMCS1622PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20

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
00763000341367Harmony™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
00643169415850Melody™ TPVMEDTRONIC, INC.NPV2014-09-23
00643169415874Melody™ TPVMEDTRONIC, INC.NPV2014-09-23