| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
| |
| Trade Name | ZIMMER(R) BONE CEMENT DOUGH-TYPE, ZIMMER(R) L.V.C.(R) LOW VIXCOSITY BONE CEMENT AND OSTEOBOND(TM) COPOLYMER BONE CEMENT |
|---|
| Classification Name | bone cement |
|---|
| Generic Name | bone cement |
|---|
| Regulation Number | 888.3027 |
|---|
| Applicant | ZIMMER, INC. |
|---|
| PMA Number | N17755 |
|---|
| Supplement Number | S045 |
|---|
| Date Received | 06/22/1995 |
|---|
| Decision Date | 10/17/1996 |
|---|
| Product Code | |
| Advisory Committee |
Orthopedic |
|---|
| Supplement Type | normal 180 day track |
|---|
| Supplement Reason | process change: sterilization |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product |
No
|
|---|
Approval Order Statement
Change in ethylene oxide sterilizatin process used in the sterilization of the external surface of the bone cement's monomer ampules. |
|
|
