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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 NameVITAGEL SURGICAL HEMOSTAT
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agent and dressing
Regulation Number878.4490
ApplicantMEDICAL DEVICE TECHNOLOGIES, INC.
PMA NumberP990030
Supplement NumberS005
Date Received08/23/2004
Decision Date09/13/2004
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new trade name for the device previously known as the costasis/dynastat surgical hemostat: the device, as modified, will be marketed under the trade name vitagel surgical hemostat and is indicated for use in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
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