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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCOSTASIS SURGICAL HEMOSTAT
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantAngiotech Medical Device Technologies
3600 S.W 47th Ave.
Gainesville, FL 32608
PMA NumberP990030
Supplement NumberS004
Date Received04/30/2002
Decision Date06/13/2002
Withdrawal Date03/07/2012
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT COHESION TECHNOLOGIES, PALO ALTO, CALIFORNIA.
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