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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 NameINSTAT ABSORBABLE COLLAGEN HEMOSTAT
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agents, collagen based
Regulation Number878.4490
ApplicantETHICON, INC.
PMA NumberP830079
Supplement NumberS014
Date Received08/25/2003
Decision Date09/26/2003
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for removal of the neurological exclusion from the "indications for use" statement. The device, as modified, will be marketed under the trade name instat absorbable collagen hemostat and is indicated for use "in surgical procedures (other than in ophthalmological surgery) as an adjunct to hemostasis when control of bleeding by ligature or other conventional procedures in ineffective or impractical. Instat hemostat can be cut to size for use in endoscopic procedures. ".
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