• 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.
 
DeviceNEW JERSEY LCS TOTAL KNEE SYSTEM
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Generic Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Applicant
DEPUY, INC.
p.o. box 988
700 orthopaedic drive
warsaw, IN 46581-0988
PMA NumberP830055
Supplement NumberS048
Date Received09/10/1996
Decision Date10/11/1996
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
PACKAGING CHANGE FROM A BLISTER PACK WITH TYVEK LID TO A CHEVRON PEEL POUCH FOR TEXTURED AND POROUS PATELLA COMPONENTS OF THE NEW JERSEY LCS TOTAL KNEE SYSTEM
-
-