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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.
 
Trade NameFOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
Classification Namemesh, surgical, polymeric
Generic Namesurgical sealant
Regulation Number878.3300
ApplicantGENZYME CORP.
PMA NumberP990028
Supplement NumberS006
Date Received01/15/2003
Decision Date02/04/2003
Product Code
FTL[ Registered Establishments with FTL ]
Advisory Committee Anesthesiology
Supplement Type Special Supplement
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revision of storage instructions in the product label.
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