PMA P040006S003

Device: CHARITE ARTIFICIAL DISC
Applicant: Depuy Spine, Inc.
PMA number: P040006
Supplement: S003
Product code: MJO
Decision date: 2006-12-15
Generic name: Prosthesis, intervertebral disc
Approval order statement: ADDITION TO THE DEPUY (IRELAND) LTD. FACILITY OF AN OPTIMAL IN-PROCESS CLEANLINE AND THREE NEW PIECES OF EQUIPMENT: A MAZAK INTEGREX MACHINING CENTRE, A SCHLICK BLAST UNIT AND A TRUMPF LASER-MARKING MACHINE.

Current openFDA PMA Record#

Device: CHARITE ARTIFICIAL DISC
Applicant: Depuy Spine, Inc.
PMA number: P040006
Supplement: S003
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2006-12-15
Decision code: OK30
Date received: 2006-11-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION TO THE DEPUY (IRELAND) LTD. FACILITY OF AN OPTIMAL IN-PROCESS CLEANLINE AND THREE NEW PIECES OF EQUIPMENT: A MAZAK INTEGREX MACHINING CENTRE, A SCHLICK BLAST UNIT AND A TRUMPF LASER-MARKING MACHINE.