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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 NumberS011
Date Received07/21/1998
Decision Date08/10/1998
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
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 flour, 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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