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
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
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