FDA.reportPublic FDA data

HeartMate 3™

Primary DI
05415067039446
Brand
HeartMate 3™
Company
Thoratec Corporation
Model
106531US
Catalog number
106531US
Device description
System Controller
Published
2025-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSQVentricular (assist) bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSQVentricular (Assist) BypassUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160054000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160054000HeartMate 3™ Left Ventricular Assist SystemABBOTT MEDICAL2017-08-23DSQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067039446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067039446054150670394465415067039446

GMDN Terms#

Term, Definition table
TermDefinition
Implantable ventricular circulatory assist system control unitAn electrically-powered external component of an implantable ventricular circulatory assist system intended to supply power to the implanted system pump via a percutaneous lead (not included). It is typically a belt worn device used as a bridge to transplantation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius25 Degrees Celsius
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
070156955
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640135140276CentriMag™201-50110201-501102022-03-29
07640135140283CentriMag™201-50112201-501122022-03-29
07640135140412CentriMag™201-50128201-501282022-03-29
07640135140429CentriMag™201-50129201-501292022-03-29
07640135140436CentriMag™201-50130201-501302022-03-29
07640135140443CentriMag™201-50131201-501312022-03-29
07640135140481CentriMag™201-50137201-501372022-03-29
07640135140566CentriMag™201-52213201-522132022-03-29
07640135140474CentriMag™1029611029612014-09-20
05415067038272HeartMate™10002151100021512022-09-12
05415067039606HeartMate™126012602025-05-16
05415067039781HeartMate™ GoGear™1042291042292025-05-16
05415067039842HeartMate™ GoGear™1042331042332025-05-16
05415067039866HeartMate™ GoGear™1042341042342025-05-16
05415067039927HeartMate™ GoGear™1064491064492025-05-16
05415067039903HeartMate™ GoGear™1061291061292025-07-21
05415067039422HeartMate 3™106531LF2106531LF22025-07-16
05415067038173HeartMate™ GoGear™1042321042322025-05-16
05415067039804HeartMate™ GoGear™1042301042302025-05-16
05415067039828HeartMate™ GoGear™1042311042312025-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000923679HeartWare™ Waist PackHeartware, Inc.DSQ2026-05-31
00763000923686HeartWare™ Shoulder PackHeartware, Inc.DSQ2026-05-31
00763000923655HeartWare™ BatteryHeartware, Inc.DSQ2026-05-01
07640135140153CentriMag™Thoratec CorporationDSQ2026-02-19
00763000989514HVAD™ ControllerHeartware Inc.DSQ2025-08-30
05415067039385HeartMate 3™Thoratec CorporationDSQ2025-07-21
05415067039545HeartMate™Thoratec CorporationDSQ2025-07-21
05415067038784HeartMate 3™Thoratec CorporationDSQ2025-07-21
05415067039880HeartMate™Thoratec CorporationDSQ2025-07-21
05415067039903HeartMate™ GoGear™Thoratec CorporationDSQ2025-07-21
05415067039422HeartMate 3™Thoratec CorporationDSQ2025-07-16
05415067037800HeartMate™Thoratec CorporationDSQ2025-05-16
05415067038821HeartMate 3™Thoratec CorporationDSQ2025-05-16
05415067039606HeartMate™Thoratec CorporationDSQ2025-05-16
05415067039644HeartMate™Thoratec CorporationDSQ2025-05-16
05415067039781HeartMate™ GoGear™Thoratec CorporationDSQ2025-05-16
05415067039842HeartMate™ GoGear™Thoratec CorporationDSQ2025-05-16
05415067039866HeartMate™ GoGear™Thoratec CorporationDSQ2025-05-16
05415067039927HeartMate™ GoGear™Thoratec CorporationDSQ2025-05-16
15415067037807HeartMate™Thoratec CorporationDSQ2025-05-16
05415067037824HeartMate™Thoratec CorporationDSQ2025-05-16
05415067038173HeartMate™ GoGear™Thoratec CorporationDSQ2025-05-16
05415067038609HeartMate™Thoratec CorporationDSQ2025-05-16
05415067038746HeartMate™Thoratec CorporationDSQ2025-05-16
05415067039040HeartMate™Thoratec CorporationDSQ2025-05-16
15415067039641HeartMate™Thoratec CorporationDSQ2025-05-16
05415067039804HeartMate™ GoGear™Thoratec CorporationDSQ2025-05-16
05415067039828HeartMate™ GoGear™Thoratec CorporationDSQ2025-05-16
05415067038456HeartMate 3™Thoratec CorporationDSQ2025-04-07
05415067039323HeartMate 3™Thoratec CorporationDSQ2025-04-02