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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameMAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE
Classification Namesuture, absorbable, synthetic, polyglycolic acid
Generic Namesuture, absorbable, synthetic, polyglycolic acid
Regulation Number878.4493
ApplicantKENDALL-SHERWOOD DAVIS & GECK MEDICAL CO.
PMA NumberP840051
Supplement NumberS008
Date Received10/30/1996
Decision Date11/15/1996
Product Code
GAM[ Registered Establishments with GAM ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of a new supplier of trimethylene carbonate.
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