PMA P910016S007

Device
NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE
Applicant
Depuy, Inc.
PMA number
P910016
Supplement
S007
Product code
MBD
Decision date
1996-01-02
Generic name
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
Approval order statement
APPROVAL OF GAS PLASMA STERILIZATION FOR POLYETHYLENE COMPONENTS

Current openFDA PMA Record

Device
NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE
Applicant
Depuy, Inc.
PMA number
P910016
Supplement
S007
Product code
MBD
Generic name
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
Decision date
1996-01-02
Decision code
APPR
Date received
1995-05-25
Supplement type
Normal 180 Day Track
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL OF GAS PLASMA STERILIZATION FOR POLYETHYLENE COMPONENTS

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