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510(k) Data Aggregation

    K Number
    K063556
    Device Name
    PERIPATCH ENDO-SLEEVE
    Manufacturer
    PM DEVICES, INC.
    Date Cleared
    2007-03-20

    (113 days)

    Product Code
    FTM
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PM DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PeriPatch Aegis is intended for reinforcing staples and suture lines during a number of resection techniques - surgical repair of tissue deficiencies such as: - Lung resections . - Biopses . - Lobectomies - Gastric banding - Abdominal and thoracic wall repair
    Device Description
    The PeriPatch Aegis is intended be used as a surgical patch reinforce surgical staples during material to stapling procedures. The PeriPatch Aegis device assembly consists of a strip of buttress material, a cartridge which mates the device to the endoscopic stapler, and finally a loader which assists the user to place the device on to the stapler.
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    K Number
    K040835
    Device Name
    PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16
    Manufacturer
    PM DEVICES, INC.
    Date Cleared
    2004-06-15

    (76 days)

    Product Code
    FTM, DXZ
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PM DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PeriPatch Sheet is intended for use as a surgical patch material for: cardiac and vascular reconstruction and repair, soft tissue deficiency repair and reinforcing the suture line during general surgical procedures.
    Device Description
    The PeriPatch™ Sheet is a quadrilateral shaped xenograft patch made from a sheet of glutaraldehyde fixed bovine pericardium selected for even thickness. It is designed to repair the body's natural organs and functions like natural tissue. It is intended for intra-cardiac repair procedures. It is identical to other marketed bovine pericardial patches. Extensive quality control procedures assure a consistent, high quality product for clinical use.
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    K Number
    K033985
    Device Name
    PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10
    Manufacturer
    PM DEVICES, INC.
    Date Cleared
    2004-06-04

    (164 days)

    Product Code
    FTM
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PM DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PeriPatch™ Sleeve is intended for use as a surgical patch mesh material to reinforce surgical staples during stapling procedures and for reinforcing suture lines for cardiovascular and general procedures. Stapling is carried out according to the stapler manufacture's instructions. The sleeves are intended for a number of resection techniques including: lung volume reductions, biopsies, lobectomies, gastric banding, rectal and vaginal prolapse, and urethral sling.
    Device Description
    PeriPatch™ Sleeve consists of one piece of The qlutaraldehyde fixed bovine pericardium that is sutured into a rectanqular shaped tube. It is intended for reinforcing surgical staples. These specially prepared sleeves are slipped over the forks of linear or endoscopic surgical staplers. Stapling is carried out according to the stapler manufacture's instructions. The suture is removed and the remaining pericardial tissue is withdrawn with the excised host tissue. The sleeves are intended for a number of resection techniques such as lung volume reductions, biopsies, lobectomies and other soft tissue repairs.
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    K Number
    K031948
    Device Name
    PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16
    Manufacturer
    PM DEVICES, INC.
    Date Cleared
    2003-09-16

    (84 days)

    Product Code
    DXZ
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    PM DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PeriPatch Sheet is intended for use as a surgical patch material for cardiac and vascular reconstruction and repair.
    Device Description
    Processed Bovine Pericardial Patch
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