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 addition to the labeling of the following warning statement: "do not centriguge osteobond copolymer bone cement. Although centrifugation has been shown in some cases to improve the physical strength of the cured cement by removal of entrapped air and other gases, a uniform dispersion of the radiopacifier cannot be assured. Therefore, the use of centrigugation is not advisable. "
| Device | OSTEOBOND(TM) COPOLYMER BONE CEMENT |
| Generic Name | Bone Cement |
| Applicant | ZIMMER, INC. |
| Date Received | 1995-10-11 |
| Decision Date | 1995-11-20 |
| PMA | N17755 |
| Supplement | S046 |
| Product Code | LOD |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |