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.
| Device | S-ROM POLY-DIAL CONSTRAINED ACETABULAR LINER |
| Generic Name | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Applicant | DEPUY, A JOHNSON & JOHNSON CO.p.o. Box 988700 Orthopaedic Drivewarsaw, IN 46581-0988 PMA NumberP960054 Supplement NumberS002 Date Received07/30/1999 Decision Date12/07/1999 Reclassified Date 05/30/2002 Product Code KWZ Advisory Committee Orthopedic Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 1999-07-30 |
| Decision Date | 1999-12-07 |
| PMA | P960054 |
| Supplement | S002 |
| Product Code | KWZ |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DEPUY, A JOHNSON & JOHNSON CO. p.o. Box 988 700 Orthopaedic Drive warsaw, IN 46581-0988 PMA NumberP960054 Supplement NumberS002 Date Received07/30/1999 Decision Date12/07/1999 Reclassified Date 05/30/2002 Product Code KWZ Advisory Committee Orthopedic Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For A Design Modification Made To The S-ROM Constrained Liner So To Be Used Withthe DePuy Duraloc And Solution Acetabular Cup Systems. 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. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960054 | Original Filing | |
| S004 | 1999-10-06 | Normal 180 Day Track |
| S003 | 1999-08-10 | Normal 180 Day Track |
| S002 | 1999-07-30 | Normal 180 Day Track |
| S001 |