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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFOCALSEAL-L SYNTHETIC ABLSORBABLE SEALANT
Generic NameMesh, surgical, polymeric
Regulation Number878.3300
ApplicantGenzyme Corp.
55 Cambridge Pkwy.
Cambridge, MA 02142
PMA NumberP990028
Supplement NumberS001
Date Received07/28/2000
Decision Date04/20/2001
Withdrawal Date02/10/2016
Product Code FTL 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE POST APPROVAL STUDY PROTOCOL PMS-0001-0.
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