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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 ABSORBABLE SEALANT
Generic NameMesh, surgical, polymeric
Regulation Number878.3300
ApplicantGenzyme Corp.
55 Cambridge Pkwy.
Cambridge, MA 02142
PMA NumberP990028
Supplement NumberS005
Date Received10/17/2002
Decision Date11/25/2002
Withdrawal Date02/10/2016
Product Code FTL 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A BOX AROUND THE CONTRAINDICATIONS SECTION OF THE INSTRUCTIONS FOR USE FOR FOCALSEAL-L SEALANT.
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