FDA.reportPublic FDA data

ANTHEM™

Primary DI
05414734503785
Brand
ANTHEM™
Company
ST. JUDE MEDICAL, INC.
Model
PM3210
Catalog number
PM3210
Device description
Cardiac Resynchronization Therapy Device, Pulse GeneratorDDDRV
Published
2017-04-10
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)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P030035053
P030035151
P030035153
P030035154
P030035175
P030035177

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030035053ANTHEM AND FRONTIER II CRT-P'SABBOTT MEDICAL2004-05-13NKE
P030035151ANTHEM AND FRONTIER II CRT-P'SABBOTT MEDICAL2004-05-13NKE
P030035153ANTHEM AND FRONTIER II CRT-P'SABBOTT MEDICAL2004-05-13NKE
P030035154ANTHEM AND FRONTIER II CRT-P'SABBOTT MEDICAL2004-05-13NKE
P030035175ANTHEM AND FRONTIER II CRT-P'SABBOTT MEDICAL2004-05-13NKE
P030035177ANTHEM AND FRONTIER II CRT-P'SABBOTT MEDICAL2004-05-13NKE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734503785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734503785054147345037855414734503785

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume13.7Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature23 Degrees Fahrenheit122 Degrees Fahrenheit
Storage Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature23 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
790268031
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067055811EnSite™ENSITE-SW-6.1ENSITE-SW-6.12026-06-01
05414734400596MTS™118311832015-04-25
05414734403382NA724172412015-03-24
05414734405157SJM™162716272015-03-12
05415067016560SJM™303230322015-07-29
05415067018533SJM™121312132015-07-29
05415067018854SJM™121412142015-07-29
05415067027863NA703270322017-11-16
05415067052933Current™A-UNI-PF-CBLA-UNI-PF-CBL2026-04-20
05415067053893Current™PFA-GEN-V102PFA-GEN-V1022026-04-20
05415067056108EnSite™ENSITE-RL-MPENSITE-RL-MP2026-04-17
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05414734400749Tennafix™120512052015-09-08
05414734405355SJM™301330132015-04-25
05415067016119NA231123112015-03-12
05415067016126SJM™23162316ANS2015-03-12
05415067016133SJM™23212321ANS2015-04-22
05415067016140NA232623262015-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067049575Merlin™ST. JUDE MEDICAL, INC.NKE2025-06-25
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
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
00643169735668Serena™ Quad 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