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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 ABSORBABLE SEALANT
Classification Namemesh, surgical, polymeric
Generic Namesurgical sealant
Regulation Number878.3300
ApplicantGENZYME CORP.
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 - other
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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