BEUDAMED
    Product Code: PMX FDA class 3 21 CFR 878.4490

    Absorbable Collagen Hemostatic Agent With Thrombin

    General, Plastic Surgery

    The Absorbable Collagen Hemostatic Agent With Thrombin (product code PMX) is a Class 3 general and plastic surgery device intended for use as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical, regulated under 878.4490. Class 3 classification requires Premarket Approval (PMA). The device is flagged as an implant and is intended for internal use to aid surgical hemostasis.

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    510(k)s
    0
    FEI Numbers
    12
    Registration Numbers
    12
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    PMX
    Device Class
    FDA class 3
    Regulation Number
    878.4490
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Intended for use as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

    FEI Numbers

    This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.