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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 MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantC.R. Bard, Inc.
160 New Boston St.
Woburn, MA 01801
PMA NumberP800002
Supplement NumberS012
Date Received05/23/2001
Decision Date06/18/2001
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  
ELIMINATION OF CERTAIN IN PROCESS OR FINAL DEVICE TESTS PERFORMED ON AVITENE COLLAGEN HEMOSTASIS (MCH) PRODUCTS. THIS WILL ELIMINATE TEST REDUNDANCY, WASTE AND/OR PROVIDE A MORE EFFICIENT UTILIZATION OF TEST SAMPLES SELECTED DURING THE PROCESSING OF AVITENE.
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