Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: LPS-FLEX MOBILE
• Classification Name: prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
• Applicant: ZIMMER, INC.
• PMA Number: P060037
• Supplement Number: S004
• Date Received: 09/02/2008
• Decision Date: 11/06/2008
• Product Code: NJL [ Registered Establishments with NJL ]
• Advisory Committee: Orthopedic
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: postapproval protocol or modification to a protocol
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval of the post-approval study protocol.