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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameAVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH)
Classification Nameagent, absorbable hemostatic, collagen based
Generic Namenon woven web hemostatic agent
Regulation Number878.4490
ApplicantMEDCHEM PRODUCTS, INC.
PMA NumberP800002
Supplement NumberS009
Date Received01/21/1992
Decision Date04/09/1993
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
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