|
Device | PRODISC -C TOTAL DISC REPLACEMENT |
Generic Name | Prosthesis, intervertebral disc |
Applicant | Centinel Spine, LLC 900 Airport Road, Suite 3B West Chester, PA 19380 |
PMA Number | P070001 |
Supplement Number | S012 |
Date Received | 03/13/2012 |
Decision Date | 12/22/2014 |
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 IN MANUFACTURING OF THE PACKAGING. |