Identity
- Trade Name
- AMPLATZER PFO OCCLUDER FDA PMA
- Generic Name
- Transcatheter septal occluder FDA PMA
Identifiers
- PMA Number
- P120021 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
The Amplatzer PFO Occluder is a transcatheter septal occluder designed for percutaneous transcatheter closure of a patent foramen ovale (PFO). It is intended to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism.
The device is used following an evaluation by a neurologist and cardiologist to exclude known causes of ischemic stroke. The Amplatzer PFO Occluder is manufactured by Abbott Medical and received FDA PMA approval on October 28, 2016, for the specified indication.
Frequently asked questions
What is the Amplatzer PFO Occluder used for?
The Amplatzer PFO Occluder is used for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between 18 and 60 years old, who have had a cryptogenic stroke due to a presumed paradoxical embolism.
How is the Amplatzer PFO Occluder implanted?
The device is implanted through a percutaneous transcatheter procedure, meaning it is inserted through a catheter in the blood vessel rather than through open surgery. The procedure is performed by cardiologists following evaluation by both a neurologist and cardiologist to confirm the patient meets the criteria for treatment.
What patient population is the Amplatzer PFO Occluder indicated for?
The device is indicated for patients predominantly between the ages of 18 and 60 years who have experienced a cryptogenic stroke due to a presumed paradoxical embolism through a PFO. These patients must have been evaluated by both a neurologist and cardiologist to rule out other known causes of ischemic stroke.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P120021 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P120021 24 fields · synced Sep 18, 2026