PMA P980052S002

Device: TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM
Applicant: Stryker Leibinger, GmbH & Co KG
PMA number: P980052
Supplement: S002
Product code: LZD
Decision date: 2003-01-14
Generic name: Joint, temporomandibular, implant
Approval order statement: APPROVAL FOR THE ADDITION OF THE STERILE PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS TO BE STERILIZED AT TMJ CONCEPTS, VENTURA, CALIFORNIA.

Current openFDA PMA Record#

Device: TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM
Applicant: Stryker Leibinger, GmbH & Co KG
PMA number: P980052
Supplement: S002
Product code: LZD
Generic name: Joint, temporomandibular, implant
Decision date: 2003-01-14
Decision code: APPR
Date received: 2002-11-27
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF THE STERILE PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS TO BE STERILIZED AT TMJ CONCEPTS, VENTURA, CALIFORNIA.