Amplatzer™

FDA UDI

Class III (US FDA UDI)

by Aga Medical Corp.

Identity

Trade Name: Amplatzer™ FDA UDI
Generic Name: Cardiac defect occluder FDA UDI
Device Name: Post Infarct Muscular VSD Occluder FDA UDI
Model / Reference: Post Infarct Muscular VSD Occluder FDA UDI
Description: Post Infarct Muscular VSD Occluder FDA UDI

Identifiers

Catalog Number: 9-VSDMPIHDE-016 FDA UDI
Primary DI / UDI-DI: 05415067028105 FDA UDI
PMA Number: H070005 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Width — 10 Millimeter FDA UDI
Height — 16 Millimeter FDA UDI

Category: Cardiac defect occluder

Amplatzer™ by Aga Medical Corp. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac defect occluder.

Amplatzer Piccolo™ — ST. JUDE MEDICAL, INC. · Class III
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Amplatzer™ Amulet™ — ST. JUDE MEDICAL, INC. · Class III
Occlutech ASD Occluder Procedure Pack — Occlutech International AB · Class III
WATCHMAN FLX™ Pro — Boston Scientific · Class III
Occlutech ASD Occluder — Occlutech GmbH · Class III
Occlutech ASD Occluder Procedure Pack — Occlutech International AB · Class III
WATCHMAN® — Boston Scientific · Class III

Cleared under the same submission

H070005 also covers:

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: Aga Medical Corp.

Sources (1)

FDA UDI 9a3297f3-560c-487a-8029-bef6ef5f7eb1 37 fields · synced May 30, 2026