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510(k) Data Aggregation

    K Number
    K072859
    Device Name
    ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES
    Date Cleared
    2008-05-23

    (231 days)

    Product Code
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNACIONAL FARMACEUTICA, S.A. DE C.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Atramat® PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.
    Device Description
    Atramat® PGLA90 Poly(glycolide-co-L-lactide) Surgical Suture are synthetic absorbable sterile coated surgical sutures composed from a copolymer of glycolide L-lactide. This product is offered as dyed with an FDA listed color additive, D&C Violet No. 2.
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    K Number
    K072863
    Device Name
    ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES
    Date Cleared
    2008-05-23

    (231 days)

    Product Code
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNACIONAL FARMACEUTICA, S.A. DE C.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Atramat® PGC25 Poly(glycolide-co-epsilon-caprolactone) Surgical Sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
    Device Description
    Atramat® Poly(glycolide-co-epsilon-caprolactone) PGC25 Surgical Suture are synthetic absorbable sterile monofilament surgical sutures composed from a copolymer of glycolide and epsilon-caprolactone. This product is offered as undyed or dyed with an FDA listed color additive, D&C Violet No. 2.
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    K Number
    K041048
    Device Name
    POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE
    Date Cleared
    2004-06-04

    (43 days)

    Product Code
    Regulation Number
    878.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNACIONAL FARMACEUTICA, S.A. DE C.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Atramat ® Synthetic Absorbable Polydioxanone Surgical Suture is indicated for use in all types of soft tissue approximation including pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. Atramat ® Synthetic Absorbable Polydioxanone Surgical Sutures are not indicated for use in adult cardiovascular, microsurgical, and neurological surgery uses.
    Device Description
    Atramat ® Monofilament Polydioxanone are synthetic absorbable sterile surgical sutures composed of poly (p-dioxanone) synthetic polymer. These products are offered as monofilament or and it is offered uncoated or coated, it could also be undyed or dyed with D&C Violet No. 2.
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    K Number
    K040282
    Device Name
    ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID
    Date Cleared
    2004-04-29

    (83 days)

    Product Code
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNACIONAL FARMACEUTICA, S.A. DE C.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Atramat ® Polyglycolic Acid Sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. sorb-FAST ® Polyglycolic Acid Sutures are indicated only for use in superficial general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. These sutures are not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.
    Device Description
    Atramat® Polyglycolic Acid and sorb-FAST® Polyglycolic Acid are synthetic absorbable sterile surgical sutures composed of a synthetic polyglycolic acid polymer. Atramat® Polyglycolic acid and sorb-FAST® Polyglycolic Acid meet all requirements as described in the United States Pharmacopeia (USP) monograph for Absorbables Surgical Sutures. These products are offered as monofilament or multifilament and it is offered uncoated or coated with polycaprolactone and calcium sterarate, it could also be undyed or dyed with D&C Violet No. 2. Sizes offered are U.S.P. 8-0 through 2 ( metric equivalent 0.4 through 5). Materials: Polyglycolic acid. USP & Polycaprolactone and Calcium Stearate
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