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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.
 
DeviceMAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE
Generic NameSuture, absorbable, synthetic, polyglycolic acid
Regulation Number878.4493
ApplicantDavis & Geck, Inc.
1 Casper St.
Danbury, CT 06810
PMA NumberP840051
Supplement NumberS008
Date Received10/30/1996
Decision Date11/15/1996
Product Code GAM 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF A NEW SUPPLIER OF TRIMETHYLENE CARBONATE.
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