Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: 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.
 
DeviceS-ROM POLY-DIAL CONSTRAINED LINER
Generic NameProsthesis, hip, constrained, cemented or uncemented, metal/polymer
Regulation Number888.3310
ApplicantDepuy, A Johnson & Johnson Co.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw, IN 46581
PMA NumberP960054
Supplement NumberS004
Date Received10/06/1999
Decision Date11/10/1999
Reclassified Date05/30/2002
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a cleaning and packaging facility located at DePuy Orthopaedics, Inc., 700 Orthopaedic Drive, Warsaw, IN 46581.
-
-