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-DAIL CONSTRAINED 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 NumberS003 Date Received08/10/1999 Decision Date12/22/1999 Reclassified Date 05/30/2002 Product Code KWZ Advisory Committee Orthopedic Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 1999-08-10 |
| Decision Date | 1999-12-22 |
| PMA | P960054 |
| Supplement | S003 |
| Product Code | KWZ |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 NumberS003 Date Received08/10/1999 Decision Date12/22/1999 Reclassified Date 05/30/2002 Product Code KWZ Advisory Committee Orthopedic Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement Approva For The Cleaning And Packaging Site Located At DePuy (Ireland) Ltd., Loughbeg, Ringaskiddy, Cork. Ireland And The Sterilization Facility Located At ISOTRON Plc, Marcus Close, Tilehurst, Reading, Berkshire FG30 4EA, England. |
| 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 |