Opinion ID: 2533543
Heading Depth: 1
Heading Rank: 4

Heading: Regulations

Text: ¶ 16. Sanders argues that Code of Federal Regulations Section 882.5880 is controlling authority for the classification of the GenesisXP, an implanted spinal-cord stimulator. ¶ 17. The Code of Federal Regulations defines an implanted spinal-cord stimulator for pain relief. See 21 C.F.R. § 882.5880 (2010). The regulation states: (a) Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulse across the patient's skin to the implanted receiver. (b) Classification. Class II (performance standards). 21 C.F.R. § 882.5880 (2010). The federal regulation also defines an implanted spinal-cord stimulator as a class II device. 21 C.F.R. § 882.5880 (2010). ¶ 18. ANS concedes that no regulation exists for a totally implantable spinal-cord stimulator. However, ANS argues that its device is distinguishable from the implanted spinal-cord stimulator defined in Section 882.5880 because the GenesisXP is totally implantable, meaning that the receiver and transmitter are both implanted, whereas the spinal-cord stimulator described in the regulation has an implanted receiver and an external transmitter for transmitting the stimulating pulse. Thus, the two devices are distinguishable.