PMA P020016S005

Device: TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
Applicant: Biomet Microfixation, Inc.
PMA number: P020016
Supplement: S005
Product code: LZD
Decision date: 2010-11-08
Generic name: Joint, temporomandibular, implant
Approval order statement: APPROVAL FOR PROPOSED LABELING CHANGES FOLLOWING THE CONCLUSION OF THE POSTMARKET STUDY FOR THE WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM.

Current openFDA PMA Record#

Device: TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
Applicant: Biomet Microfixation, Inc.
PMA number: P020016
Supplement: S005
Product code: LZD
Generic name: Joint, temporomandibular, implant
Decision date: 2010-11-08
Decision code: APPR
Date received: 2010-05-18
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: APPROVAL FOR PROPOSED LABELING CHANGES FOLLOWING THE CONCLUSION OF THE POSTMARKET STUDY FOR THE WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM.