S-ROM POLY-DIAL CONSTRAINED LINER

FDA Premarket Approval P960054 S004

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.

Pre-market Approval Supplement Details

• Device: S-ROM POLY-DIAL 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 NumberS004 Date Received10/06/1999 Decision Date11/10/1999 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: 1999-10-06
• Decision Date: 1999-11-10
• PMA: P960054
• Supplement: S004
• 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 NumberS004 Date Received10/06/1999 Decision Date11/10/1999 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 ; Approval For A Cleaning And Packaging Facility Located At DePuy Orthopaedics, Inc., 700 Orthopaedic Drive, Warsaw, IN 46581.

Supplemental Filings

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