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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.
Classification Namemesh, surgical, polymeric
Generic Namemesh, surgical, polymeric
Regulation Number878.3300
55 cambridge parkway
cambridge, MA 02142
PMA NumberP990028
Supplement NumberS002
Date Received01/09/2001
Decision Date07/16/2001
Product Code
FTL[ Registered Establishments with FTL ]
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing facility located at chesapeake biological laboratories, inc. , baltimore, md. The facility will perform the aseptic formulation and filling of primer vial 2 of focalseal-l synthetic absorbable sealant.