PMA P020016S001

Device: TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
Applicant: Biomet Microfixation, Inc.
PMA number: P020016
Supplement: S001
Product code: LZD
Decision date: 2006-05-26
Generic name: Joint, temporomandibular, implant
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT WALTER LORENZ SURGICAL, INC.S JACKSONVILLE, FLORIDA FACILITY FOR THE WIRE ELECTRICAL DISCHARGE MACHINING MANUFACTURING PROCESS.

Current openFDA PMA Record#

Device: TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
Applicant: Biomet Microfixation, Inc.
PMA number: P020016
Supplement: S001
Product code: LZD
Generic name: Joint, temporomandibular, implant
Decision date: 2006-05-26
Decision code: APPR
Date received: 2006-04-28
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT WALTER LORENZ SURGICAL, INC.S JACKSONVILLE, FLORIDA FACILITY FOR THE WIRE ELECTRICAL DISCHARGE MACHINING MANUFACTURING PROCESS.