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U.S. Department of Health and Human Services

Devices@FDA
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY/FLOUR/SYRINGEAVITENE/CAST MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH)
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantDavol Inc., Sub. C. R. Bard, Inc.
100 Crossings Blvd.
Warwick, RI 02886
PMA NumberN17600
Supplement NumberS026
Date Received12/22/2011
Decision Date01/23/2012
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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."
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