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.
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.
Device | 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 |
PMA | N18331 |
Supplement | S027 |
Product Code | NEW |
Advisory Committee | General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | ETHICON, INC. route 22 West p.o. Box 151 somerville, NJ 08876-0151 |
Supplement Number | Date | Supplement Type |
---|---|---|
N18331 | Original Filing | |
S027 | 1996-09-23 | Normal 180 Day Track |
S026 | 1995-08-08 | Normal 180 Day Track |
S025 | 1995-05-24 | Normal 180 Day Track |
S024 | 1994-02-14 | Normal 180 Day Track |
S023 | 1993-04-01 | Normal 180 Day Track |
S022 | 1990-02-23 | Normal 180 Day Track |
S021 | 1989-04-21 | Normal 180 Day Track |
S020 | 1987-09-01 | Special (immediate Track) |
S019 | 1987-08-12 | Normal 180 Day Track |
S018 | 1987-02-05 | Normal 180 Day Track |
S017 | 1986-10-28 | Normal 180 Day Track |
S016 | 1985-03-08 | |
S015 | 1983-12-08 | |
S014 | 1983-08-08 | |
S013 | 1983-05-05 | |
S012 | 1983-03-17 | |
S011 | 1983-03-04 | |
S010 | 1983-02-24 | |
S009 | 1982-12-20 | |
S008 | 1982-10-18 | |
S007 | 1982-03-04 | |
S006 | 1982-02-25 | |
S005 | 1982-02-25 | |
S004 | 1982-01-25 | |
S003 | 1982-01-15 | |
S002 | 1982-01-15 | |
S001 | 1981-12-28 |