FDA.reportPublic FDA data

Consulta® CRT-P

Primary DI
00613994713667
Brand
Consulta® CRT-P
Company
MEDTRONIC, INC.
Model
C4TR01
Device description
CRT C4TR01 CONSULTA CRT-P US MR
Published
2014-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKEPulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
NVZPulse generator, permanent, implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKEPulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)Unknown3
NVZPulse Generator, Permanent, ImplantableUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P010015084
P010015270
P010015286
P010015353
P010015397

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010015084MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEMMedtronic, Inc.2001-08-28LWP
P010015270MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEMMedtronic, Inc.2001-08-28LWP
P010015286MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEMMedtronic, Inc.2001-08-28LWP
P010015353MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEMMedtronic, Inc.2001-08-28LWP
P010015397MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEMMedtronic, Inc.2001-08-28LWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994713667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994713667006139947136676139947136670613994713667

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac resynchronization therapy implantable pacemakerA sterile, battery-powered, hermetically-sealed pulse generator, intended to be implanted beneath the skin of the chest in a surgically-created pocket, and used with pacing leads placed in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber) to stimulate the heart to beat at a faster rate when it senses bradycardia and provides cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions to treat symptoms of heart failure (e.g., easy fatigue) and serious heart-rhythm problems [CRT pacemaker (CRT-P)]; it is not intended for defibrillation therapy.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-18 Degrees Celsius55 Degrees Celsius
Handling Environment Temperature0 Degrees Fahrenheit131 Degrees Fahrenheit

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
Serial number
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
05415067049575Merlin™ST. JUDE MEDICAL, INC.NKE2025-06-25
00763000812058NAMEDTRONIC, INC.NVZ2025-04-12
05415067050045Neutrino™ST. JUDE MEDICAL, INC.NKE2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.NKE2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.NKE2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.NKE2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.NKE2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.NKE2025-02-11
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.NKE2024-11-13
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.NVZ2024-11-13
00763000378356Instrument Command LibraryMEDTRONIC, INC.NVZ2024-05-04
00763000378363Device Command LibraryMEDTRONIC, INC.NVZ2024-05-04
04035479173937Solvia Rise SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173944Solvia Rise DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173982Amvia Edge SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173999Amvia Edge DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174002Amvia Edge HF-T QPBIOTRONIK SE & Co. KGNKE2023-07-12
04035479174019Amvia Sky SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174026Amvia Sky DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174033Amvia Sky HF-TBIOTRONIK SE & Co. KGNKE2023-07-12
04035479174040Amvia Sky HF-T QPBIOTRONIK SE & Co. KGNKE2023-07-12
00763000612658MyCareLink™MEDTRONIC, INC.NVZ2023-05-13
00763000612665MyCareLink™MEDTRONIC, INC.NVZ2023-05-13
05415067040404NAST. JUDE MEDICAL, INC.NKE2023-01-09
00763000688400CareLink SmartSync™MEDTRONIC, INC.NVZ2022-10-28
00763000688479NAMEDTRONIC, INC.NVZ2022-10-28
00763000688479NAMEDTRONIC, INC.NKE2022-10-28
05415067031174Merlin™ST. JUDE MEDICAL, INC.NKE2022-08-29
05415067037121Merlin™ST. JUDE MEDICAL, INC.NKE2022-08-29
00763000181321NAMEDTRONIC, INC.NVZ2021-06-12