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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.
Classification Namesealant,polymerizing
Generic Namesealant,polymerizing
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.