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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.
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
311 enterprise dr.
plainsboro, NJ 08540
PMA NumberP850010
Supplement NumberS018
Date Received04/15/2003
Decision Date05/05/2003
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes effecting manufacturing processes including: 1) qualifying additional space in the same facility for the enzyme treatment process using the same dedicated equipment, 2) equipping the alkali treatment processing vessels with a dedicated temperature probe and chart recorder to continuously monitor and record product in the vessels during processing, 3) use of an additional manufacturing area, and 4) using a microwave moisture analyzer, instead of a dry heat oven, for drying the weighted samples of alkali treated collagen slices.