Amplatzer™ Talisman™

FDA UDI

Class III (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name: Amplatzer™ Talisman™ FDA UDI
Generic Name: Cardiac defect occluder FDA UDI
Device Name: PFO Occluder FDA UDI
Model / Reference: 9-PFO-3525 FDA UDI
Description: PFO Occluder FDA UDI

Identifiers

Catalog Number: 9-PFO-3525 FDA UDI
Primary DI / UDI-DI: 05415067033345 FDA UDI
FDA Product Code: MLV FDA UDI
GMDN Term: Cardiac defect occluder FDA UDI

Classification

Device Class: Class III 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 9.0000 French FDA UDI
Outer Diameter — 35.0000 Millimeter FDA UDI

Category: Cardiac defect occluder

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

Similar devices

Also classified as Cardiac defect occluder.

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AMPLATZER™ — Aga Medical Corp. · Class III
Amplatzer™ — Aga Medical Corp. · Class III
Amplatzer™ — Aga Medical Corp. · Class III
Occlutech ASD Occluder — Occlutech GmbH · Class III
Occlutech ASD Occluder Procedure Pack — Occlutech International AB · Class III

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: St. Jude Medical, Inc.

Sources (1)

FDA UDI e660dbe3-6348-4fa6-9e35-bd9196448328 36 fields · synced May 30, 2026