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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSURGICAL SNOW ABSORBABLE HEMOSTAT
Generic NameAgent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
ApplicantETHICON, INC.
1000 Route 202
Raritan, NJ 08869
PMA NumberN12159
Supplement NumberS030
Date Received03/09/2012
Decision Date04/26/2012
Product Code LMG 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES INCLUDING UPDATED GRAPHICS, INSTRUCTIONS FOR USE, AND LANGUAGE TRANSLATIONS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGICEL SNOW ABSORBABLE HEMOSTAT AND IS INDICATED FOR: SURGICEL ABSORBABLE HEMOSTAT (OXIDIZED REGENERATED CELLULOSE) IS USED ADJUNCTIVELY IN SURGICAL PROCEDURES TO ASSIST IN THE CONTROL OF CAPILLARY, VENOUS, AND SMALL ARTERIAL HEMORRHAGE WHEN LIGATION OR OTHER CONVENTIONAL METHODS OF CONTROL ARC IMPRACTICAL OR INEFFECTIVE. SURGICEL ORIGINAL, SURGICEL FIBRILLAR, SURGICEL NUKNIT AND SURGICEL SNOW HEMOSTATS CAN BE CUT TO SIZE FOR USE IN ENDOSCOPIC PROCEDURES. SURGICEL ABSORBABLE HEMOSTAT (OXIDIZED REGENERATED CELLULOSE) IS INDICATED FOR ADJUNCTIVE USE TO ASSIST IN THE CONTROL OF BLEEDING IN EXODONTIA AND ORAL SURGERY. IT MAY ALSO BE USED TO HELP ACHIEVE HEMOSTASIS AFTER SINGLE OR MULTIPLE TOOTH EXTRACTIONS, ALVEOLOPLASTY, GINGIVAL HEMORRHAGE, IMPACTIONS, BIOPSIES, AND OTHER PROCEDURES IN THE ORAL CAVITY.
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