|
Device | X-STOP LTOS |
Generic Name | Prosthesis, spinous process spacer/plate |
Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P040001 |
Supplement Number | S021 |
Date Received | 08/05/2013 |
Decision Date | 12/12/2014 |
Withdrawal Date
|
04/30/2015 |
Product Code |
NQO |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN UPDATE TO THE X STOP® INTERSPINOUS SPACER SYSTEM LABELING TO REFLECT THE RESULTS FROM THE LONG TERM OUTCOMES STUDY (LTOS) THAT WAS CONDUCTED AS A POSTAPPROVAL STUDY REQUIREMENT. |
Post-Approval Study | Show Report Schedule and Study Progress |