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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
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantStryker Corp.
2825 Airview Blvd.
Kalamazoo, MI 49002
PMA NumberP050044
Supplement NumberS017
Date Received01/28/2011
Decision Date02/25/2011
Withdrawal Date07/10/2019
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF AN ALTERNATE LOCATION FOR CONDUCTING TWO MICROBIOLOGICAL ASSAYS USED IN THE MANUFACTURE OF THE VITAGEL SURGICAL HEMOSTAT.
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