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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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 MICROFIBBRILLAR COLLAGEN HEMOSTAT PRODUCTS- NON-WOVEN WEB, ULTRAFOAM, FLOUR 1 G SYRINGE, ENDO AVITENE
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 NumberS029
Date Received05/30/2014
Decision Date06/26/2014
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
FOIL POUCH SUPPLIER FACILITY SITE CHANGE AND THE PROPOSED REMOVAL OF A REJECTION CRITERION FOR COMPONENT ACCEPTANCE IN AN IN-PROCESS INSPECTION STEP FOR THE AVITENE PRODUCT FAMILY.
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