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U.S. Department of Health and Human Services

Product Classification

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Device absorbable collagen hemostatic agent with thrombin
Regulation Description Absorbable hemostatic agent and dressing.
Definition Intended for use as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Physical State collagen plus thrombin
Technical Method Hemostatic agent combining tamponade and acceleration of fibrin clot formation
Target Area Surgical procedures other than ophthalmic
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodePMX
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Infection Control and 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
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible