PMA N18331

Device: PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED
Applicant: ETHICON, Inc.
PMA number: N18331
Supplement: S027
Product code: NEW
Decision date: 1997-05-12
Generic name: Suture, surgical, absorbable, polydioxanone
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.

Current openFDA PMA Record#

Device: PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED
Applicant: ETHICON, Inc.
PMA number: N18331
Supplement: S027
Product code: NEW
Generic name: Suture, surgical, absorbable, polydioxanone
Decision date: 1997-05-12
Decision code: APPR
Date received: 1996-09-23
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.