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.
Change in ethylene oxide sterilizatin process used in the sterilization of the external surface of the bone cement's monomer ampules
Device | ZIMMER(R) BONE CEMENT DOUGH-TYPE, ZIMMER(R) L.V.C.(R) LOW VIXCOSITY BONE CEMENT AND OSTEOBOND(TM) COPOLYMER BONE CEMENT |
Generic Name | Bone Cement |
Applicant | ZIMMER, INC. |
Date Received | 1995-06-22 |
Decision Date | 1996-10-17 |
PMA | N17755 |
Supplement | S045 |
Product Code | LOD |
Advisory Committee | Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | ZIMMER, INC. p.o. Box 708 warsaw, IN 46581-0708 |
Supplement Number | Date | Supplement Type |
---|---|---|
N17755 | Original Filing | |
S049 | 1997-05-01 | Normal 180 Day Track |
S048 | 1996-08-30 | Normal 180 Day Track |
S047 | 1996-06-21 | Real-time Process |
S046 | 1995-10-11 | Special (immediate Track) |
S045 | 1995-06-22 | Normal 180 Day Track |
S044 | 1994-08-01 | Normal 180 Day Track |
S043 | 1994-07-08 | Special (immediate Track) |
S042 | 1994-06-13 | Normal 180 Day Track |
S041 | 1992-09-18 | Normal 180 Day Track |
S040 | 1992-05-28 | Special (immediate Track) |
S039 | 1992-02-18 | Normal 180 Day Track |
S038 | ||
S037 | 1990-02-08 | Normal 180 Day Track |
S036 | 1990-01-12 | Normal 180 Day Track |
S035 | 1990-01-08 | Special (immediate Track) |
S034 | 1988-04-12 | 30-Day Supplement |
S033 | 1986-09-03 | Normal 180 Day Track |
S032 | ||
S031 | 1984-08-24 | |
S030 | ||
S029 | 1983-01-03 | |
S028 | 1982-10-26 | |
S027 | 1982-08-18 | |
S026 | 1982-08-06 | |
S025 | 1982-07-07 | |
S024 | 1982-02-11 | |
S023 | ||
S022 | 1981-06-29 | |
S021 | 1981-05-22 | |
S020 | ||
S019 | 1980-09-01 | |
S018 | ||
S017 | ||
S016 | ||
S015 | ||
S014 | ||
S013 | ||
S012 | ||
S011 | ||
S010 | ||
S009 | ||
S008 | ||
S007 | ||
S006 | ||
S005 | ||
S004 | ||
S003 | ||
S002 | ||
S001 |