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U.S. Department of Health and Human Services

Product Classification
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Device transcatheter septal occluder (atrial)
Definition For the treatment of defects in the atrial septum and closure of atrial septal defects via transcatheter technique.
Physical State permanent implant placed in septum (usually constructed of a combination of metals/polymers that is placed via a venous catheter system)
Technical Method percutaneous venous puncture and interventional technique
Target Area cardiac atrial septum
Review Panel Cardiovascular
Product CodeOZG
Premarket Review Office of Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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