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510(k) Data Aggregation
K Number
K072859Device Name
ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES
Manufacturer
Date Cleared
2008-05-23
(231 days)
Product Code
Regulation Number
878.4493Why 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
K072863Device Name
ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES
Manufacturer
Date Cleared
2008-05-23
(231 days)
Product Code
Regulation Number
878.4493Why 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
K041048Device Name
POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE
Manufacturer
Date Cleared
2004-06-04
(43 days)
Product Code
Regulation Number
878.4840Why 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
K040282Device Name
ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID
Manufacturer
Date Cleared
2004-04-29
(83 days)
Regulation Number
878.4493Why 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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