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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameFOCAL SEAL-L SYNTHETIC ABSORBABLE SEALANT
Classification Namesealant,polymerizing
Generic Namesurgical sealant
ApplicantGENZYME CORP.
PMA NumberP990028
Date Received06/07/1999
Decision Date05/26/2000
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the focalseal-l synthetic absorbable sealant.
Approval Order Approval Order
Supplements: S001 S002 S005 S006 S007 
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