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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
2825 airview boulevard
portage, MI 49002
PMA NumberP050044
Supplement NumberS012
Date Received01/04/2010
Decision Date07/23/2010
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at orthovita, inc. In malvern, pennsylvania.