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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.
 
DeviceSURGICEL® Absorbable Hemostats (SURGICEL® SNOW™)
Generic NameAgent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
ApplicantETHICON, Inc.
1000 Rte. 202
Raritan, NJ 08869
PMA NumberN12159
Supplement NumberS115
Date Received08/02/2024
Decision Date08/28/2024
Product Code LMG 
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  
a manufacturing change to Expand Controlled Manufacturing Environment (CME) area for SURGICELTM SNoW Absorbable Hemostats manufactured at Ethicon LLC San Lorenzo, Puerto Rico
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