Amplatzer Septal Occluder & Multi-Fenestrated Septal Occluder Cribriform

FDA PMA

Class III (US FDA PMA)

PMA P000039

by Abbott Medical

Identity

Trade Name: THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM FDA PMA
Generic Name: Transcatheter septal occluder FDA PMA

Identifiers

PMA Number: P000039 FDA PMA
FDA Product Code: MLV FDA PMA

Classification

Device Class: Class III FDA PMA
Advisory Committee: Cardiovascular FDA PMA
FDA Decision: APPR Approved FDA PMA

Amplatzer Septal Occluder & Multi-Fenestrated Septal Occluder Cribriform by Abbott Medical (transcatheter septal occluder) — Class III — FDA_PMA — listed in…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA PMA	United States	FDA_PMA	P000039	Class III	Active

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Manufacturer

Manufacturer: Abbott Medical

Sources (1)

FDA PMA P000039 24 fields · synced Jun 18, 2026