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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 NumberS007
Date Received11/12/2003
Decision Date12/04/2003
Withdrawal Date02/10/2016
Product Code FTL 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR COMPLAINT RETURN AND INVESTIGATION OPERATIONS TO BE TRANSFERRED FROM THE GENZYME FACILITY IN LEXINGTON, MASSACHUSETTS TO THE GENZYME FACILITY IN FARMINGHAM, MASSACHUSETTS.
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