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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.
 
DevicePDS II (POLYDIOXANOE) SUTURE DYED & UNDYED
Generic NameSuture, surgical, absorbable, polydioxanone
Regulation Number878.4840
ApplicantEthicon, Inc.
Route 22 W. P.O. Box 151
Somerville, NJ 08876-0151
PMA NumberN18331
Supplement NumberS027
Date Received09/23/1996
Decision Date05/12/1997
Product Code NEW 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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