FDA.reportPublic FDA data

Aveir™

Primary DI
05415067031914
Brand
Aveir™
Company
ST. JUDE MEDICAL, INC.
Model
LSL02
Catalog number
LSL02
Device description
Link Module Programmer Communication Module
Published
2023-03-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWOPulse-generator, single chamber, sensor driven, implantable
PNJLeadless pacemaker

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWOPulse-Generator, Single Chamber, Sensor Driven, ImplantableUnknown3
PNJLeadless PacemakerCardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150035000Aveir VR Leadless SystemABBOTT MEDICAL2022-03-31PNJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067031914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067031914054150670319145415067031914

GMDN Terms#

Term, Definition table
TermDefinition
Intracardiac pacemaker programming interface unitAn external, electronic device intended to interface a dedicated patient lead (cable with skin surface electrodes) with a pacemaker programmer (from which it draws its power), to enable noninvasive interrogation and programming of an implanted intracardiac pacemaker using high frequency electrical pulses (as an alternative to wireless communication); it is also intended to collect electrocardiogram (ECG) data for observation of pacemaker function. Pacemaker communication and ECG data collection is achieved via the patient cable/electrodes which are typically included. The device is intended to be used by a healthcare professional in a clinical setting.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit104 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
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067030092Advisor™H702532H7025322019-09-23
05415067031471Advisor™H702520H7025202019-09-23
05415067017031WorkMate Claris™H701703H7017032017-04-06
05415067024756EnSite Precision™ Link, Sensor Enabled™H702475H7024752016-12-20
05415067026149N/AH702499H7024992016-12-08
05415067026163EnSite™H702498-TH702498-T2016-12-20
05415067026194EnSite™H702500H7025002016-12-08
05415067026200EnSite™H702500-TH702500-T2016-12-08
05415067052742Epic™ESP300-23ESP300-232026-07-08
05415067052759Epic™EELT-23AEELT-23A2026-07-08
05415067052766Epic™EELT-31MEELT-31M2026-07-08
05415067052780Epic™EELT-27MEELT-27M2026-07-08
05415067052797Epic™ESP300-25ESP300-252026-07-08
05415067052803Epic™ESP300-19ESP300-192026-07-08
05415067052810Epic™EELT-19AEELT-19A2026-07-08
05415067052827Epic™EELT-29MEELT-29M2026-07-08
05415067052834Epic™EELT-27AEELT-27A2026-07-08
05415067052858Epic™EELT-25AEELT-25A2026-07-08
05415067052865Epic™EELT-21AEELT-21A2026-07-08
05415067052872Epic™EELT-33MEELT-33M2026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067051189AVEIR™ST. JUDE MEDICAL, INC.PNJ2025-08-07
05415067049575Merlin™ST. JUDE MEDICAL, INC.LWO2025-06-25
05415067050045Neutrino™ST. JUDE MEDICAL, INC.LWO2025-02-11
05415067050045Neutrino™ST. JUDE MEDICAL, INC.PNJ2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.LWO2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.PNJ2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.PNJ2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.LWO2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.LWO2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.PNJ2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.LWO2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.PNJ2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.PNJ2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.LWO2025-02-11
05415067049971AVEIR™ST. JUDE MEDICAL, INC.PNJ2024-12-12
05415067046468AVEIR™ST. JUDE MEDICAL, INC.PNJ2024-12-11
05415067046475AVEIR™ST. JUDE MEDICAL, INC.PNJ2024-12-11
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.LWO2024-11-13
05415067040701Aveir™ST. JUDE MEDICAL, INC.PNJ2023-09-12
05415067040725Aveir™ST. JUDE MEDICAL, INC.PNJ2023-09-12
05415067038487Aveir™ST. JUDE MEDICAL, INC.PNJ2023-08-15
00763000078645Micra™ AV2MEDTRONIC, INC.PNJ2023-05-05
00763000078683Micra™ VR2MEDTRONIC, INC.PNJ2023-05-05
05415067034472Aveir™ST. JUDE MEDICAL, INC.PNJ2023-03-03
05415067034472Aveir™ST. JUDE MEDICAL, INC.LWO2023-03-03
05415067036384Aveir™ST. JUDE MEDICAL, INC.PNJ2023-03-03
05415067036384Aveir™ST. JUDE MEDICAL, INC.LWO2023-03-03
05415067040404NAST. JUDE MEDICAL, INC.LWO2023-01-09
05415067031174Merlin™ST. JUDE MEDICAL, INC.LWO2022-08-29
05415067037121Merlin™ST. JUDE MEDICAL, INC.LWO2022-08-29