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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(R) 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 NumberS015
Date Received07/21/1998
Decision Date08/10/1998
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  
Requested the elimination of the in-vivo hemostasis test, a heavy metals test done at an intermediate bulk stage of Avitene MCH Flur, and the routine performance of finished product sterility testing as part of the sterilization release criteria for each lot of product sterilized.
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