|
Device | PRODISC - L TOTAL DISC REPLACEMENT |
Generic Name | Prosthesis, intervertebral disc |
Applicant | Centinel Spine, LLC 900 Airport Road, Suite 3B West Chester, PA 19380 |
PMA Number | P050010 |
Supplement Number | S011 |
Date Received | 01/28/2011 |
Decision Date | 09/16/2011 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO A NEW CALIBRATION SOFTWARE PROGRAM. |