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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 NameSURGICEL, SURGICEL NU-KNIT FIBRILLAR ABSORBABLE HEMOSTAT
Classification Nameagent, absorbable hemostatic, non-collagen based
Generic Nameabsorbable hemostatic agents, collagen based
Regulation Number878.4490
ApplicantETHICON, INC.
PMA NumberN12159
Supplement NumberS017
Date Received08/28/1998
Decision Date05/05/1999
Product Code
LMG[ Registered Establishments with LMG ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional location for the final product release located at ethicon, inc. , u. S. Route 22, somerville, nj 08876 and duplication of final packaging process at ethicon, inc. , road 183 km 8. 3, industrial area hato, san lorenzo, puerto rico 00754.
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