Talent Occluder W Occluder Delivery System

FDA-Cleared Indications

• The FDA indication text provided for PMA P070027 is: "Implement an electronic laboratory management system."
• The product code MIH identifies an endovascular graft system for aortic aneurysm treatment, but the available record does not provide a specific approved Talent Occluder clinical indication.

Clinical Applications

Reported off-label uses

• Occlusion of selected vessels or vascular segments during endovascular treatment may be described in clinical practice for devices of this type, but the supplied FDA labeling does not establish these uses for this record.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• Confirm the current FDA labeling and approval order before using this record to guide clinical care; the indication text appears inconsistent with the device name and product code.
• Device size, delivery-system compatibility, and access-vessel suitability must be confirmed from the manufacturer’s instructions for use.
• Placement generally requires fluoroscopic or other intravascular imaging guidance by clinicians trained in endovascular procedures.
• MRI safety and conditional-use requirements cannot be determined from the supplied record; consult the current labeling before MRI.
• Potential risks of endovascular occlusion devices include malposition, migration, vessel injury, unintended ischemia, bleeding, thrombosis, and need for additional treatment.