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 terminology of "half batch, single batch, double batch, half pack, single pack, and double pack" to the package labels for osteobond copolymer bone cement
| Device | OSTEOBOND(TM) COPOLYMER BONE CEMENT |
| Generic Name | Bone Cement |
| Applicant | ZIMMER, INC. |
| Date Received | 1996-06-21 |
| Decision Date | 1996-07-31 |
| PMA | N17755 |
| Supplement | S047 |
| Product Code | LOD |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| 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 |