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Idiomas disponibles
• The minimally invasive transcatheter procedure with low procedural risk as demonstrated in the RESPECT trial, where
the overall device- or procedure-related serious adverse event (SAE) rate was <5%
• May prevent the need for long-term antithrombotic therapy.
Summary of Safety and Clinical Performance
A summary of the safety and clinical performance for this device is available at https://ec.europa.eu/tools/eudamed. Search
for the device using the UDI-DI provided on the outer packaging of the device. This is the SSCP location after the launch of
the European Database on Medical Devices/Eudamed.
Patient Identification Card
Complete the Patient Identification Card provided in the outer box with the patient's name, implant date, and your name or
healthcare facility information along with the contact phone number. Record device information (model number, lot number,
UDI number) or apply the label provided in the sterile package in the designated section of the card.
Give the completed card to the patient. To obtain a replacement card if a patient loses or damages their card, contact Abbott
Medical Technical Support.
Product Materials
The following materials are intended to come into contact with tissue:
Table 1. Product Material Composition by Weight
Material Description
Polyester Sheet
Polyester Filament Yarn
and Staple Fiber
Nitinol Wire
Platinum/ 20% Iridium alloy
316L/316LVM Stainless Steel
1. Saver, Jeffrey L., John D. Carroll, David E. Thaler, Richard W. Smalling, Lee A. MacDonald, David S. Marks, and David L. Tirschwell. "Long-term outcomes
of patent foramen ovale closure or medical therapy after stroke," New England Journal of Medicine 377, no. 11 (2017): 1022–1032.
Substances in Material
Polyethylene Terephthalate
Binder Resin
Polyester Blend
Nickel
Titanium
Cobalt
Iron
Carbon
Oxygen
Niobium
Copper
Chromium
Hydrogen
Nitrogen
Platinum
Iridium
Iron
Chromium
Nickel
Molybdenum
Manganese
Silicon
Nitrogen
Phosphorus
Carbon
Sulfur
4
Percent Concentration (% w/w)
1 - 5
<1
<1
>30
>30
<1
<1
<1
<1
<1
<1
<1
<1
<1
1 - 5
<1
1 - 5
1 - 5
<1
<1
<1
<1
<1
<1
<1
<1
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