FDA.reportPublic FDA data

Serena™ Quad CRT-P MRI SureScan™

Primary DI
00643169735668
Brand
Serena™ Quad CRT-P MRI SureScan™
Company
MEDTRONIC, INC.
Model
W4TR02
Device description
CRTP W4TR02 SERENA QUAD CRTP MRI US
Published
2017-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P010015317
P010015338
P010015340
P010015391
P010015399
P010015411
P010015439
P010015463

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010015317MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEMMedtronic, Inc.2001-08-28LWP
P010015338MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEMMedtronic, Inc.2001-08-28LWP
P010015340MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEMMedtronic, Inc.2001-08-28LWP
P010015391MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEMMedtronic, Inc.2001-08-28LWP
P010015399MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEMMedtronic, Inc.2001-08-28LWP
P010015411MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEMMedtronic, Inc.2001-08-28LWP
P010015439MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEMMedtronic, Inc.2001-08-28LWP
P010015463MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEMMedtronic, Inc.2001-08-28LWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169735668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169735668006431697356686431697356680643169735668

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
Storage 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
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23
00199150080700NABB11E27R32026-05-23
00199150081004NABB11J58R82026-05-23
00199150081011NABB12T50R32026-05-23
00199150081035NABB7E31R342026-05-22
00199150081042NA12D63R22026-05-22
00199150081066NA4J31R12026-05-23
00199150081707NABB11J59R92026-05-22
00199150081714NABB11U73R22026-05-23
00199150081738NABB11J16R32026-05-22
00199150081745NA9M68R12026-05-23
00199150082902NABB12W52R2026-05-22
00613994963819Sones™ C0087202016-06-05
00613994963833NIH™0087622016-07-24
00613994963840NIH™0087632016-06-10
00613994963987Sones™ Brachial0077702016-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
04035479174002Amvia Edge HF-T QPBIOTRONIK SE & Co. KGNKE2023-07-12
04035479174033Amvia Sky HF-TBIOTRONIK SE & Co. KGNKE2023-07-12
04035479174040Amvia Sky HF-T QPBIOTRONIK SE & Co. KGNKE2023-07-12
05415067040404NAST. JUDE MEDICAL, INC.NKE2023-01-09
00763000688479NAMEDTRONIC, INC.NKE2022-10-28
05415067031174Merlin™ST. JUDE MEDICAL, INC.NKE2022-08-29
05415067037121Merlin™ST. JUDE MEDICAL, INC.NKE2022-08-29
05414734510080Quadra Allure™ST. JUDE MEDICAL, INC.NKE2019-01-15
05414734510097Quadra Allure MP™ST. JUDE MEDICAL, INC.NKE2019-01-15
00763000060428NAMEDTRONIC, INC.NKE2018-12-16
00643169891401Percepta™ CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-10-20
00643169891418Percepta™ Quad CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-10-20
00643169891425Serena™ CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-10-20
00643169891432Serena™ Quad CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-10-20
00643169891449Solara™ CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-10-20
00643169891456Solara™ Quad CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-10-20
00643169735637Percepta™ CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-06-18
00643169735651Serena™ CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-06-18
00643169735675Solara™ CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-06-18
00643169735682Solara™ Quad CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-06-18
00643169855519NAMEDTRONIC, INC.NKE2017-05-25