PMA P000028S003

Device: AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000028
Supplement: S003
Product code: MAX
Decision date: 2003-07-02
Generic name: Intervertebral fusion device with bone graft, lumbar
Approval order statement: APPROVAL FOR ADDITIONAL MANUFACTURING FACILITY TO PERFORM PACKAGING FOR TERMINAL STERILIZATION. THE FACILITY IS LOCATED AT MEDTRONIC SOFAMOR DANEK, WARSAW, INDIANA. ALSO, APPROVAL FOR AN ADDITIONAL STERILIZATION FACILITY LOCATED AT IBA STERIGENICS, WESTERVILLE, OHIO AND AN ADDITIONAL TESTING FACILITY LOCATED AD NAMSA, NORTHWOOD, OHIO.

Current openFDA PMA Record#

Device: AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000028
Supplement: S003
Product code: MAX
Generic name: Intervertebral fusion device with bone graft, lumbar
Decision date: 2003-07-02
Decision code: APPR
Date received: 2002-11-08
Supplement type: Normal 180 Day Track
Supplement reason: Express GMP Supplement
Approval order statement: APPROVAL FOR ADDITIONAL MANUFACTURING FACILITY TO PERFORM PACKAGING FOR TERMINAL STERILIZATION. THE FACILITY IS LOCATED AT MEDTRONIC SOFAMOR DANEK, WARSAW, INDIANA. ALSO, APPROVAL FOR AN ADDITIONAL STERILIZATION FACILITY LOCATED AT IBA STERIGENICS, WESTERVILLE, OHIO AND AN ADDITIONAL TESTING FACILITY LOCATED AD NAMSA, NORTHWOOD, OHIO.