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U.S. Department of Health and Human Services

Product Classification

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Device barrier, adhesion, cardiovascular
Definition Indicated to reduce the incidence, severity or extent of adhesions/tissue attachment in cardiovascular surgery by providing a plane of dissection or mechanical barrier between opposing surfaces of tissue and/or devices. Intended for use in cardiac surgery to prevent or reduce adhesions, and facilitate reoperation in patients who are anticipated to need staged cardiovascular surgeries or repeat procedures in the thoracic region.
Physical State a resorbable synthetic polymeric material that is either a sheet of material or a spray liquid
Technical Method the barrier may be either placed in the area of concern, or sutured in place, or sprayed onto the area
Target Area thoracic region
Review Panel Cardiovascular
Product CodeOBD
Premarket Review 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
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible