PMA P910016S014

Device
UNICOMPARTMENTAL DEVICE CONFIGURATION OF THE LCS TOTAL KNEE SYSTEM
Applicant
Depuy, Inc.
PMA number
P910016
Supplement
S014
Product code
MBD
Decision date
2005-09-26
Classification
Orthopedic
Generic name
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
Approval order statement
APPROVAL FOR CHANGES TO THE POST-APPROVAL STUDY.

Current openFDA PMA Record#

Device
UNICOMPARTMENTAL DEVICE CONFIGURATION OF THE LCS TOTAL KNEE SYSTEM
Applicant
Depuy, Inc.
PMA number
P910016
Supplement
S014
Product code
MBD
Generic name
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
Decision date
2005-09-26
Decision code
APPR
Date received
2005-05-23
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
APPROVAL FOR CHANGES TO THE POST-APPROVAL STUDY.