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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 Nameagent, absorbable hemostatic, non-collagen based
Generic Nameagent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
ApplicantETHICON, INC.
PMA NumberN12159
Supplement NumberS013
Date Received09/15/1993
Decision Date01/16/1996
Product Code
LMG[ Registered Establishments with LMG ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval 1)process change that deletes the use of the in-process solvent freon and replaces it with perfluorohexane 2) change of in-process manufacturing facility to noramco, inc. , 1440 olympic dr. , p. O. Box 800001, athens, ga 30608-8001 3)change of quality assurance site to, johnson and johnson medical, inc. , u. S. Highway 75s and 1417w, sherman, tx 75091-9100 4)addition of alternate sterilization site, johnson & johnson medical, inc. , u. S. Highway 75s and 1417w, sherman, tx 75091-9100.