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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceFOCAL SEAL-L SYNTHETIC ABSORBABLE SEALANT
Classification Namesealant,polymerizing
Generic Namesealant,polymerizing
Applicant
GENZYME CORP.
55 cambridge parkway
cambridge, MA 02142
PMA NumberP990028
Date Received06/07/1999
Decision Date05/26/2000
Withdrawal Date 02/10/2016
Product Code
NBE[ Registered Establishments with NBE ]
Docket Number 00M-1507
Notice Date 09/11/2000
Advisory Committee Anesthesiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S005 S006 S007 
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