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Amplatzer Talisman PFO Occluder | PFO Closure Device

    https://www.cardiovascular.abbott/us/en/hcp/products/structural-heart/structural-interventions/amplatzer-talisman.html
    The Amplatzer™ Talisman™ PFO Occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in …

Amplatzer Septal Occluders for ASD Closure | Abbott

    https://www.cardiovascular.abbott/us/en/hcp/products/structural-heart/structural-interventions/amplatzer-septal.html
    The AMPLATZER™ Cribriform Occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the closure of multifenestrated (cribriform) atrial septal …

The AMPLATZER® Septal Occluder System …

    https://www.accessdata.fda.gov/cdrh_docs/pdf/P000039b.pdf
    Device Trade Name: AMPLATZER® Septal Occluder and AMPLATZER® Delivery System Applicant's Name and Address: AGA Medical Corporation 682 …

Amplatzer Amulet LAA Occluder | Abbott

    https://www.cardiovascular.abbott/us/en/hcp/products/structural-heart/structural-interventions/amplatzer-amulet.html
    The Amplatzer™ Amulet™ device contains a nickeltitanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from …

Amplatzer Vascular Plug 4 (AVP 4) | Abbott

    https://www.cardiovascular.abbott/us/en/hcp/products/peripheral-intervention/amplatzer-family-vascular-plugs/avp-4.html
    A patient with the Amplatzer™ Vascular Plug 4 may be safely scanned under the following conditions. Failure to follow these conditions may result in injury to the patient. Device Name: …

Amplatzer Duct Occluders for PDA Closure | Abbott

    https://www.cardiovascular.abbott/us/en/hcp/products/structural-heart/structural-interventions/amplatzer-pda.html
    The Amplatzer Family of Duct Occluders offers an extensive line of devices and a simple treatment option for the closure of patent ductus arteriosus (PDA). Amplatzer™ Duct …

International Medical Devices Database

    https://medicaldevices.icij.org/manufacturers/agencia-espanola-de-medicamentos-y-productos-sanitarios-via-foi-aga-medical-corporation
    AGA Medical Corporation. “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country …

MAUDE Adverse Event Report: AGA MEDICAL …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7045456
    On (b) (6) 2017, a 25mm amplatzer pfo occluder (pfo) was implanted to a patient with platypnea orthodeoxia (positional dyspnea) using tte. After the pfo closure the patient …

MAUDE Adverse Event Report: AGA MEDICAL …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6976363
    An event of a deformed 25 mm amplatzer pfo occluder (pfo) was reported. The results of the investigation are inconclusive since the device was not returned for analysis. The device …

MAUDE Adverse Event Report: AGA MEDICAL …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3231731&pc=MLV
    AGA MEDICAL CORPORATION AMPLATZER MUSCULAR VSD OCCLUDER CARDIAC OCCLUSION DEVICE: Back to Search Results: Model Number 9-VSD-MUSC-018: ...



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