Identity
- Trade Name
- NIT-OCCLUD PDA FDA PMA
- Generic Name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS FDA PMA
Identifiers
- PMA Number
- P120009 FDA PMA
- FDA Product Code
- MAE FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The NIT-OCCLUD PDA is a permanently implanted prosthesis designed for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus with a minimum angiographic diameter less than 4 mm. This device is manufactured by Pfm Medical, Inc. and is intended for use in cardiovascular procedures.
The NIT-OCCLUD PDA is supplied as a single-use device and requires appropriate storage conditions. It has received FDA PMA approval for the specified indication. The device is classified under product code MAE and is manufactured in Carlsbad, California.
Frequently asked questions
What is the NIT-OCCLUD PDA device used for?
The NIT-OCCLUD PDA is a permanently implanted prosthesis specifically designed for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus (PDA) with a minimum angiographic diameter less than 4 mm. It is intended to be used in cardiovascular procedures to close the PDA, a congenital heart defect where the ductus arteriosus fails to close after birth.
What are the regulatory approvals for the NIT-OCCLUD PDA?
The NIT-OCCLUD PDA has received FDA PMA (Pre-market Approval) authorization, with approval granted on August 16, 2013. The device is classified under product code MAE and is manufactured by Pfm Medical, Inc. in Carlsbad, California. The FDA approval specifically indicates the device for closing small to moderate size patent ductus arteriosus with a minimum angiographic diameter less than 4 mm.
Is the NIT-OCCLUD PDA reusable or single-use?
The NIT-OCCLUD PDA is supplied as a single-use device. This means it is designed for one patient use only and should not be reused or resterilized. The device must be stored according to the manufacturer's specifications to maintain its integrity and functionality until the time of use.
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 | P120009 | Class III | Active |
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Manufacturer
- Manufacturer
- Pfm Medical, Inc.
Sources (1)
- FDA PMA P120009 24 fields · synced Sep 18, 2026