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Stimulator, Intracerebral/Subcortical, Implanted

Page Type
Product Code
Definition
Call for PMAs to be filed by 3/1/89 per 53 FR 43621 on 12/1/88
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
PMA
Device Classification
Class 3
Regulation Number
882.5840
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5840 Implanted intracerebral/subcortical stimulator for pain relief

§ 882.5840 Implanted intracerebral/subcortical stimulator for pain relief.

(a) Identification. An implanted intracerebral/subcortical stimulator for pain relief is a device that applies electrical current to subsurface areas of a patient's brain to treat severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed within a patient's brain and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

(b) Classification. Class III (premarket approval).

(c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 1, 1989, for any implanted intracerebral/subcortical stimulator for pain relief that was in commercial distribution before May 28, 1976, or that has on or before March 1, 1989, been found to be substantially equivalent to an implanted intracerebral/subcortical stimulator for pain relief that was in commercial distribution before May 28, 1976. Any other implanted intracerebral/subcortical stimulator for pain relief shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[44 FR 51730, Sept. 4, 1979, as amended at 53 FR 48621, Dec. 1, 1988]

Stimulator, Intracerebral/Subcortical, Implanted

Page Type
Product Code
Definition
Call for PMAs to be filed by 3/1/89 per 53 FR 43621 on 12/1/88
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
PMA
Device Classification
Class 3
Regulation Number
882.5840
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5840 Implanted intracerebral/subcortical stimulator for pain relief

§ 882.5840 Implanted intracerebral/subcortical stimulator for pain relief.

(a) Identification. An implanted intracerebral/subcortical stimulator for pain relief is a device that applies electrical current to subsurface areas of a patient's brain to treat severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed within a patient's brain and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

(b) Classification. Class III (premarket approval).

(c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 1, 1989, for any implanted intracerebral/subcortical stimulator for pain relief that was in commercial distribution before May 28, 1976, or that has on or before March 1, 1989, been found to be substantially equivalent to an implanted intracerebral/subcortical stimulator for pain relief that was in commercial distribution before May 28, 1976. Any other implanted intracerebral/subcortical stimulator for pain relief shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[44 FR 51730, Sept. 4, 1979, as amended at 53 FR 48621, Dec. 1, 1988]