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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™ ORIGINAL Absorbable Hemostat, SURGICEL™ Nu-Knit Absorbable Hemostat, SURGICEL™ Fibrillar Absorbable Hemostat,
Generic NameAgent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
ApplicantEthicon, Inc.
1000 Route 202
Raritan, NJ 08869
PMA NumberN12159
Supplement NumberS083
Date Received08/12/2021
Decision Date09/10/2021
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  
Addition of new and duplicate equipment to support automation of the operations and increase manufacturing capacity at the Ethicon, LLC, San Lorenzo, Puerto Rico facility.
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