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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
Generic NameSealant, polymerizing
ApplicantGENZYME 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 
Docket Number 00M-1507
Notice Date 09/11/2000
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S005 S006 S007 
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