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510(k) Data Aggregation

    K Number
    K061790
    Device Name
    PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
    Manufacturer
    PROTEIN POLYMER TECHNOLOGIES, INC.
    Date Cleared
    2006-09-19

    (85 days)

    Product Code
    KRD, HCG
    Regulation Number
    870.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROTEIN POLYMER TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PVA particles are indicated for arterial embolization of arteriovenous malformations (AVMs) and hypervascular tumors in the peripheral vasculature, and for vascular occlusion of blood vessels within the neurovascular system for the embolization of AVMs and neoplastic lesions.
    Device Description
    The subject devices are particles of nonabsorbable synthetic polyvinyl alcohol (PVA) foam. The devices do not contain any colorant or other additive, and are uncol ted. Each is offered in a range of particle sizes, from which the clinician may saleot the particle size most appropriate for the desired effect and targeted vasculature. The devices are delivered to the selected vascular location by means of a syringe, through an infusion catheter of diameter appropriate for the selected particle size.
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    K Number
    K053548
    Device Name
    MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
    Manufacturer
    PROTEIN POLYMER TECHNOLOGIES, INC.
    Date Cleared
    2006-01-30

    (41 days)

    Product Code
    HCG
    Regulation Number
    882.5950
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROTEIN POLYMER TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations (AVMs) and neoplastic lesions when presurgical devascularization is desirable.
    Device Description
    The subject devices are particles of nonabsorbable synthetic polyvinyl alcohol (Pva) foam. The devices do not contain any colorant or other additive, and are uncoated. Each is offered in a range of particle sizes, from which the clinician may select the particle size most appropriate for the desired effect and targeted vasculature. The devices are intended to be delivered to the selected anatomical site by means of a syringe, through an infusion catheter of appropriate diameter. The devices are provided sterile, non-pyrogenic, and are intended for single-use.
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