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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.
 
DeviceFLOSEAL ENDOSCOPIC APPLICATOR
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
Applicant
BAXTER HEALTHCARE CORP.
32650 n wilson rd
round lake, IL 60073
PMA NumberP990009
Supplement NumberS024
Date Received09/22/2008
Decision Date10/24/2008
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Additional cleaning procedure and inspection procedure at two (2) contract vendors and an inspection procedure at the baxter manufacturing facility located n irvine, california.
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