PMA N17600S026

Device: AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY/FLOUR/SYRINGEAVITENE/CAST MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH)
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S026
Product code: LMF
Decision date: 2012-01-23
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR THE ADDITION OF A PRECAUTIONS SECTION TO THE INSTRUCTIONS FOR USE FOR THE AVITENE FAMILY OF PRODUCTS. THE ADDITIONAL LANGUAGE IS AS FOLLOWS: "ANY EXCESS AVITENE MCH NOT REMOVED AT THE TIME OF SURGERY MAY EITHER PRESENT ITSELF AS A (RECURRING) MASS OR A (SPACE OCCUPYING) LESION OR IT MAY LEAD TO A FOREIGN BODY REACTION THAT MAY PRESENT WITH OR WITHOUT CLINICAL SIGNS AND SYMPTOMS AS A RECURRING MASS OR LESION OR POSTOPERATIVE ABSCESS FORMATION UPON IMAGING. IMAGING MAY INITIALLY NOT BE CAPABLE OF DISTINGUISHING THE DIFFERENCE. REMOVAL OF EXCESS MATERIAL, IDEALLY PERFORMED UPON CONCLUSION OF THE INITIAL PROCEDURE, TYPICALLY RESOLVES ALL SIGNS AND SYMPTOMS."

Current openFDA PMA Record#

Device: AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY/FLOUR/SYRINGEAVITENE/CAST MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH)
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S026
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2012-01-23
Decision code: APPR
Date received: 2011-12-22
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF A PRECAUTIONS SECTION TO THE INSTRUCTIONS FOR USE FOR THE AVITENE FAMILY OF PRODUCTS. THE ADDITIONAL LANGUAGE IS AS FOLLOWS: "ANY EXCESS AVITENE MCH NOT REMOVED AT THE TIME OF SURGERY MAY EITHER PRESENT ITSELF AS A (RECURRING) MASS OR A (SPACE OCCUPYING) LESION OR IT MAY LEAD TO A FOREIGN BODY REACTION THAT MAY PRESENT WITH OR WITHOUT CLINICAL SIGNS AND SYMPTOMS AS A RECURRING MASS OR LESION OR POSTOPERATIVE ABSCESS FORMATION UPON IMAGING. IMAGING MAY INITIALLY NOT BE CAPABLE OF DISTINGUISHING THE DIFFERENCE. REMOVAL OF EXCESS MATERIAL, IDEALLY PERFORMED UPON CONCLUSION OF THE INITIAL PROCEDURE, TYPICALLY RESOLVES ALL SIGNS AND SYMPTOMS."