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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Namesuture, surgical, absorbable, polydioxanone
Generic Namesuture, absorbable, synthetic, polyglycolic acid
Regulation Number878.4840
ApplicantETHICON, INC.
PMA NumberN18331
Supplement NumberS027
Date Received09/23/1996
Decision Date05/12/1997
Product Code
NEW[ Registered Establishments with NEW ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of pds ii (polydioxanone) suture as a component of the ethicon endosuture system and for the addition of ethicon ltd. , scotland, (ethicon, ltd. , p. O. Box 408, bankhead ave. , edinburgh, scotland and ethicon, ltd. , kirkton campus, livingston, west lothian, scotland) as a manufacturer of pds ii suture used in the ethicon endosuture system and for the assembly of the system components. The device, as modified, will be marketed under the trade name ethicon endosuture system and is indicated for use in alltypes of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. Pds ii suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.