PMA P060018S003

Device
PRESTIGE CERVICAL DISC
Applicant
Medtronic Sofamor Danek, Inc.
PMA number
P060018
Supplement
S003
Product code
MJO
Decision date
2013-07-12
Generic name
Prosthesis, intervertebral disc
Approval order statement
CHANGE THE STERILIZATION TESTING PROCEDURE.

Current openFDA PMA Record#

Device
PRESTIGE CERVICAL DISC
Applicant
Medtronic Sofamor Danek, Inc.
PMA number
P060018
Supplement
S003
Product code
MJO
Generic name
Prosthesis, intervertebral disc
Decision date
2013-07-12
Decision code
OK30
Date received
2013-06-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE THE STERILIZATION TESTING PROCEDURE.