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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 ABLSORBABLE SEALANT
Classification Namemesh, surgical, polymeric
Generic Namesurgical sealant
Regulation Number878.3300
ApplicantFOCAL, INC.
PMA NumberP990028
Supplement NumberS001
Date Received07/28/2000
Decision Date04/20/2001
Product Code
FTL[ Registered Establishments with FTL ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the post approval study protocol pms-0001-0.
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