|Trade Name||RESTORE FAMILY OF NEUROSTIMULATOR SYSTEMS|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Generic Name||stimulator, spinal-cord, totally implanted for pain relief|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Reduction in the sampling frequency of routine environmental monitoring at the facility located in juncos, puerto rico.