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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 NameSURGIFOAM HEMOSTATIC MATRIX AND SURGIFLO HEMOSTATIC MATRIX KIT WITH THROMBIN
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable gelatin sponge, usp
Regulation Number878.4490
ApplicantFERROSAN MEDICAL DEVICES A/S
PMA NumberP990004
Supplement NumberS019
Date Received10/29/2010
Decision Date05/17/2011
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Review Memo Review Memo
Approval Order Statement 
Approval for the introduction of a new hemostatic matrix formulation, redesign of the application components, reorganization of the packaging, and addition of evithrom lyophilized thrombin labeling directly into the directions for use as well as other updated labeling changes.
Approval Order Approval Order
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