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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 RT3 SUTGICAL HEMOSTAT
Generic NameAbsorbable collagen hemostatic agent with thrombin
Regulation Number878.4490
ApplicantSTRYKER CORP.
2825 AIRVIEW BOULEVARD
PORTAGE, MI 49002
PMA NumberP050044
Supplement NumberS033
Date Received01/31/2017
Decision Date03/02/2017
Withdrawal Date 07/10/2019
Product Code PMX 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
New tray tooling fixture, new sealing parameters and increased outer tray dimensions.
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