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U.S. Department of Health and Human Services

Product Classification
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Device intracardiac patch or pledget, biologically derived
Regulation Description Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
Definition To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.
Physical State The device is a biologic tissue, typically in the form of a sheet. The tissue may be decellularized or crosslinked, and may be derived from human or animal sources.
Technical Method The device is sutured into the intended site to repair or support the native tissue.
Target Area Heart and vasculature
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePSQ
Premarket Review Office of Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.3470
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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