- Device
- S-ROM POLY-DIAL CONSTRAINED LINER
- Applicant
- Depuy, A Johnson & Johnson Co.
- PMA number
- P960054
- Supplement
- S004
- Product code
- KWZ
- Generic name
- Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
- Decision date
- 1999-11-10
- Decision code
- APPR
- Date received
- 1999-10-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a cleaning and packaging facility located at DePuy Orthopaedics, Inc., 700 Orthopaedic Drive, Warsaw, IN 46581.