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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.
 
DeviceCOSEAL SURGICAL SEALANT (PREMIXED)
Classification Namesealant,polymerizing
Generic Namesealant,polymerizing
Applicant
ANGIOTECH MEDICAL DEVICE TECHNOLOGIES
3600 s.w 47th avenue
gainesville, FL 32608
PMA NumberP010022
Supplement NumberS001
Date Received08/09/2002
Decision Date02/04/2003
Product Code
NBE[ Registered Establishments with NBE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR: 1) CHANGE IN PACKAGING OF THE POLYMER RESINS TO A PRE-MIXED CONFIGURATION; 2) CHANGE IN BUFFER A TO A DILUTE HYDROGEN CHLORIDE SOLUTION WITH A PH OF 2.2; 3) CHANGE IN STERILIZATION TO GAMMA RADIATION; AND 4) CHANGE TO ROOM TEMPERATURE STORAGE.
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