Nit-Occlud PDA

FDA UDI

Class III (US FDA UDI)

by Pfm Medical, Inc.

Identity

Trade Name: Nit-Occlud PDA FDA UDI
Generic Name: Cardiac defect occluder FDA UDI
Device Name: Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with spiral coils. The system consists of a spiral coil mounted in a straightened fashion on a flexible delivery system including a disposable handle. The Nit-Occlud® PDA has a cone in cone configuration which results from the fact that the proximal windings of the coil are wound the reverse direction. Nit-Occlud® PDA is available as Flexible and Medium Type. The flexible and medium types are pre-loaded into the transportation sheath. FDA UDI
Model / Reference: 145065V2 FDA UDI
Description: Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with spiral coils. The system consists of a spiral coil mounted in a straightened fashion on a flexible delivery system including a disposable handle. The Nit-Occlud® PDA has a cone in cone configuration which results from the fact that the proximal windings of the coil are wound the reverse direction. Nit-Occlud® PDA is available as Flexible and Medium Type. The flexible and medium types are pre-loaded into the transportation sheath. FDA UDI

Identifiers

Catalog Number: 145065V2 FDA UDI
Primary DI / UDI-DI: 04042301159977 FDA UDI
PMA Number: P120009 FDA UDI
FDA Product Code: MAE 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Cardiac defect occluder

Nit-Occlud PDA by Pfm Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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AMPLATZER™ — Aga Medical Corp. · Class III
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Amplatzer™ — Aga Medical Corp. · Class III

Cleared under the same submission

P120009 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: Pfm Medical, Inc.

Sources (1)

FDA UDI bbd2b187-c612-47e7-b84d-a6192d8ba267 37 fields · synced May 30, 2026