|
Device | X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM |
Generic Name | Prosthesis, spinous process spacer/plate |
Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P040001 |
Supplement Number | S007 |
Date Received | 06/06/2007 |
Decision Date | 10/04/2007 |
Withdrawal Date
|
04/30/2015 |
Product Code |
NQO |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MODIFIED VERSION OF THE TISSUE EXPANDER OF THE TITANIUM VERSION OF THE X-STOP SPACER ASSEMBLY. |