PMA P910016S005

Device: NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE
Applicant: Depuy, Inc.
PMA number: P910016
Supplement: S005
Product code: MBD
Decision date: 1995-12-13
Generic name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
Approval order statement: APPROVAL OF MINIMUM DOSE GAMMA IRRADIATION VALIDATION FOR POLYETHYLENE COMPONENTS

Current openFDA PMA Record

Device: NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE
Applicant: Depuy, Inc.
PMA number: P910016
Supplement: S005
Product code: MBD
Generic name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
Decision date: 1995-12-13
Decision code: APPR
Date received: 1995-04-14
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL OF MINIMUM DOSE GAMMA IRRADIATION VALIDATION FOR POLYETHYLENE COMPONENTS