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
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

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