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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.
 
DeviceVITAGEL SURGICAL HEMOSTAT (VITAGEL)
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
Applicant
STRYKER CORP.
2825 airview boulevard
portage, MI 49002
PMA NumberP050044
Supplement NumberS026
Date Received11/14/2013
Decision Date02/11/2014
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE FOLLOWING CHANGES TO THE VITAPREP PLASMA SEPARATOR COMPONENT OF VITAGEL SURGICAL HEMOSTAT: ADDITION OF HYDRAFOAM AND SILICONE O-RING INSERTS TO THE INSIDE OF THE CAP, INCREASE IN THE LENGTH OF THE PLUNGER STOPPER SUPPORT, REMOLDING OF THE CAP, AND UPDATE IN THE PRIMARY PACKAGING.
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