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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.
 
DeviceSUPERSTAT
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantSuperstat Corp.
2015 University Dr.
Rancho Dominguez, CA 90220
PMA NumberP810040
Supplement NumberS006
Date Received10/21/1988
Decision Date01/30/1989
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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