S-ROM POLY-DIAL CONSTRAINED LINER
FDA premarket approval P960054 · decided 1997-06-19
Approval details
- PMA number
- P960054
- Trade name
- S-ROM POLY-DIAL CONSTRAINED LINER
- Generic name
- Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
- Applicant
- Depuy, A Johnson & Johnson Co.
- Date received
- 1996-12-26
- Decision date
- 1997-06-19
- Days to decision
- 175 days
- Decision code
- APRL
- Product code
- KWZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- 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.
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