PMA P020016S004

Device: TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
Applicant: Biomet Microfixation, Inc.
PMA number: P020016
Supplement: S004
Product code: LZD
Decision date: 2010-01-29
Generic name: Joint, temporomandibular, implant
Approval order statement: APPROVAL FOR CHANGES TO THE PACKAGING MATERIALS OF BOTH THE FOSSA AND THE MANDIBULAR TMJ SYSTEM COMPONENTS, AND EXTENSION OF THE SHELF LIFE OF THESE DEVICES TO 5 YEARS.

Current openFDA PMA Record#

Device: TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
Applicant: Biomet Microfixation, Inc.
PMA number: P020016
Supplement: S004
Product code: LZD
Generic name: Joint, temporomandibular, implant
Decision date: 2010-01-29
Decision code: APPR
Date received: 2009-12-02
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGES TO THE PACKAGING MATERIALS OF BOTH THE FOSSA AND THE MANDIBULAR TMJ SYSTEM COMPONENTS, AND EXTENSION OF THE SHELF LIFE OF THESE DEVICES TO 5 YEARS.