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 of a second location to manufacture osteobond copolymer bone cement.
| Device | OSTEOBOND(TM) COPOLYMER BONE CEMENT |
| Generic Name | Bone Cement |
| Applicant | ZIMMER, INC. |
| Date Received | 1997-05-01 |
| Decision Date | 1997-09-05 |
| PMA | N17755 |
| Supplement | S049 |
| Product Code | LOD |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location 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 |