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U.S. Department of Health and Human Services

Product Classification

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Device transcatheter septal occluder (ventricular)
Definition For the treatment of defect in the ventricular septum and closure of ventricular 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 catheter system
Technical Method percutaneous puncture and interventional technique
Target Area cardiac ventricular septum
Review Panel Cardiovascular
Product CodeOZH
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible