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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.
 
DeviceARISTA AH ABSORBABLE HEMOSTAT
Generic NameAgent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
ApplicantDavol, Inc.
100 Crossings Blvd.
Warwick, RI 02886
PMA NumberP050038
Supplement NumberS005
Date Received05/09/2008
Decision Date06/23/2008
Product Code LMG 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A NEW TRADE NAME. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEMOSTASE MPH AND IS INDICATED FOR USE IN SURGICAL PROCEDURES (EXCEPT NEUROLOGICAL AND OPHTHALMIC) AS AN ADJUNCTIVE HEMOSTATIC DEVICE TO ASSIST WHEN CONTROL OF CAPILLARY, VENOUS, AND ARTERIAL BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES ARE INEFFECTIVE OR IMPRACTICAL.
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