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U.S. Department of Health and Human Services

Product Classification
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Device agent, absorbable hemostatic, collagen with polymeric additives
Regulation Description Absorbable hemostatic agent and dressing.
Definition An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood.
Physical State gelatin based patch/mesh impregnated with polymeric agents
Technical Method mechanical tamponade
Target Area liver
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeSGV
Premarket Review Plastic and Reconstructive Surgery Devices (DHT4B)
Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type PMA
Regulation Number 878.4490
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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