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Aveir™

FDA UDI

Class III (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name
Aveir™ FDA UDI
Generic Name
Intracardiac pacemaker FDA UDI
Device Name
Leadless Pacemaker FDA UDI
Model / Reference
LSP112V FDA UDI
Description
Leadless Pacemaker FDA UDI

Identifiers

Catalog Number
LSP112V FDA UDI
Primary DI / UDI-DI
05415067034472 FDA UDI
PMA Number
P150035 FDA UDI
FDA Product Code
PNJ FDA UDI
GMDN Term
Intracardiac pacemaker FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
870.3610 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Intracardiac pacemaker

Aveir™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intracardiac pacemaker.

Cleared under the same submission

P150035 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
St. Jude Medical, Inc.

Sources (1)

  • FDA UDI 32e41fdc-01cc-4412-8016-c62db89d3d4b 37 fields · synced Jun 8, 2026