|Trade Name||X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM|
|Classification Name||prosthesis, spinous process spacer/plate|
|Generic Name||interspinous process prosthesis|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the revision of the physician guides and instructions for use to clarify the conditions under which the x-stop may be re-sterilized and to provide revised and more detailed instructions regarding attachment of the wing assembly to the spacer assembly.