PMA P020016S008

Device: TOTAL TEMPOROMANDIBULAR JOINT (TMJ) REPLACEMENT SYSTEM
Applicant: Biomet Microfixation, Inc.
PMA number: P020016
Supplement: S008
Product code: LZD
Decision date: 2017-06-08
Generic name: Joint, temporomandibular, implant
Approval order statement: APPROVAL FOR PROPOSED LABELING CHANGES FOLLOWING THE CONCLUSION OF THE POSTMARKET SURVEILLANCE STUDY FOR THE TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM.

Current openFDA PMA Record#

Device: TOTAL TEMPOROMANDIBULAR JOINT (TMJ) REPLACEMENT SYSTEM
Applicant: Biomet Microfixation, Inc.
PMA number: P020016
Supplement: S008
Product code: LZD
Generic name: Joint, temporomandibular, implant
Decision date: 2017-06-08
Decision code: APPR
Date received: 2016-12-14
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 SURVEILLANCE STUDY FOR THE TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM.