PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED
FDA premarket approval N18331/S027 · decided 1997-05-12
Approval details
- PMA number
- N18331
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED
- Generic name
- Suture, surgical, absorbable, polydioxanone
- Applicant
- ETHICON, Inc.
- Date received
- 1996-09-23
- Decision date
- 1997-05-12
- Days to decision
- 231 days
- Decision code
- APPR
- Product code
- NEW
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Somerville, NJ
- 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 I
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