| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
| |
| Device | S-ROM POLY-DIAL CONSTRAINED LINER |
|---|
| Generic Name | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
|---|
| Regulation Number | 888.3310 |
|---|
| Applicant | DEPUY, A JOHNSON & JOHNSON CO.
P.O. BOX 988
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988 |
|---|
| PMA Number | P960054 |
|---|
| Date Received | 12/26/1996 |
|---|
| Decision Date | 06/19/1997 |
|---|
|
Reclassified Date
|
05/30/2002 |
|---|
| Product Code |
KWZ |
| Docket Number | 97M-0416 |
|---|
| Notice Date | 10/07/1997 |
|---|
| Advisory Committee |
Orthopedic |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
Approval Order Statement
APPROVAL FOR THE JOHNSON AND JOHNSON'S S-ROM POLY-DIAL CONSTRAINED ACETABULAR LINER. THIS DEVICE IS INDICATED FOR USE AS A COMPONENT OF A TOTAL HIP PROSTHESIS IN PRIMARY OR REVISION PATIENTS AT HIGH RISK OF HIP DISLOCATION DUE TO A HISTORY OF PRIOR DISLOCATION, BONE LOSS, JOINT OR SOFT TISSUE LAXITY, NEUROMUSCULAR DISEASE OR INTRAOPERATIVE INSTABILITY. |
| Supplements: |
S002 S003 S004 |
|
|
