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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(R) MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH)
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agents, collagen based
Regulation Number878.4490
ApplicantMEDCHEM PRODUCTS, INC.
PMA NumberN17600
Supplement NumberS013
Date Received01/23/1995
Decision Date12/27/1995
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
Approval Order Statement 
Approval for an alternative finished device facility at 160 new boston street, woburn, ma 01801.
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