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U.S. Department of Health and Human Services

Product Classification
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Device collagen surgical mesh containing drugs
Regulation Description Surgical mesh.
Definition Reinforcement of soft tissue where weakness exists.
Physical State An acellular, sterile, non-pyrogenic porcine dermal matrix . The graft is packed dry and must be hydrated in sterile saline prior to use. The thickness of the device is 1.5 to 2.3mm. The device surfaces are coated with an antimicrobial coating, which is comprised of a bioresorbable L-tyrosine succinate polymer and antimicrobial agents Rifampin and Minocycline at 180 µg/cm2 each.
Technical Method Used to reinforce soft tissue defects, e.g., hernias, etc...
Target Area soft tissues
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodePIJ
Premarket Review Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 878.3300
Device Class 2
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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