FDA.reportPublic FDA data

Aveir™

Primary DI
05415067040701
Brand
Aveir™
Company
ST. JUDE MEDICAL, INC.
Model
LSP201A
Catalog number
LSP201A
Device description
Leadless Pacemaker
Published
2023-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PNJLeadless pacemaker

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNJLeadless PacemakerCardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150035003

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150035003Aveir VR Leadless SystemABBOTT MEDICAL2022-03-31PNJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067040701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067040701054150670407015415067040701

GMDN Terms#

Term, Definition table
TermDefinition
Intracardiac pacemakerA battery-powered, hermetically-sealed pulse generator impregnated with a steroid (e.g., dexamethasone) intended to be implanted with a catheter, via transvenous access, into the right ventricle (i.e., single-chamber pacing) of an arrhythmic heart to generate/conduct electrical impulses to improve cardiac output. It contains sensors to detect changes in the body (e.g., motion, breathing frequency) and to adjust the pacing rate accordingly (rate-responsive). Wireless telemetry with external devices enables programming adjustments and may allow on-going heart monitoring; it does not provide defibrillation therapy. Disposable devices associated with implantation may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit
Special Storage Condition, Specify00Storage excursions permitted from 59°- 86° F (15°- 30°C). Store at room temperature 25°C (77°F). Keep dry. Keep away from sunlight.
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 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
Combination product
true
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
05415067051189AVEIR™ST. JUDE MEDICAL, INC.PNJ2025-08-07
05415067050045Neutrino™ST. JUDE MEDICAL, INC.PNJ2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.PNJ2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.PNJ2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.PNJ2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.PNJ2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.PNJ2025-02-11
05415067049971AVEIR™ST. JUDE MEDICAL, INC.PNJ2024-12-12
05415067046468AVEIR™ST. JUDE MEDICAL, INC.PNJ2024-12-11
05415067046475AVEIR™ST. JUDE MEDICAL, INC.PNJ2024-12-11
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
05415067031914Aveir™ST. JUDE MEDICAL, INC.PNJ2023-03-03
05415067034472Aveir™ST. JUDE MEDICAL, INC.PNJ2023-03-03
05415067036384Aveir™ST. JUDE MEDICAL, INC.PNJ2023-03-03
00763000078621Micra™ AVMEDTRONIC, INC.PNJ2020-02-02
00643169711761Micra™MEDTRONIC, INC.PNJ2018-01-13
05414734509732Merlin.netST. JUDE MEDICAL, INC.PNJ2016-05-04
00643169529748Micra™MEDTRONIC, INC.PNJ2016-04-18
05414734509725Merlin™ST. JUDE MEDICAL, INC.PNJ2016-01-27