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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
Classification Namemesh, surgical, polymeric
Generic Namemesh, surgical, polymeric
Regulation Number878.3300
Applicant
GENZYME CORP.
55 cambridge parkway
cambridge, MA 02142
PMA NumberP990028
Supplement NumberS007
Date Received11/12/2003
Decision Date12/04/2003
Product Code
FTL[ Registered Establishments with FTL ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
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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