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Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

Page Type
Product Code
Definition
The device is intended to stimulate the phrenic nerve to produce diaphragm movement during sleep.
Physical State
The device may include an implantable pulse generator (IPG), respiratory sensing and stimulation leads. The device may also include external components such as a physician programmer.
Technical Method
The device is an implanted nerve stimulator which provides electrical stimulation of the phrenic nerve in order to contract the diaphragm and stimulate the patient to take a breath.
Target Area
Phrenic nerve
Review Panel
Anesthesiology
Submission Type
PMA
Device Classification
Class 3
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code PSR to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:

  • The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
  • The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
  • The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.

Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

Page Type
Product Code
Definition
The device is intended to stimulate the phrenic nerve to produce diaphragm movement during sleep.
Physical State
The device may include an implantable pulse generator (IPG), respiratory sensing and stimulation leads. The device may also include external components such as a physician programmer.
Technical Method
The device is an implanted nerve stimulator which provides electrical stimulation of the phrenic nerve in order to contract the diaphragm and stimulate the patient to take a breath.
Target Area
Phrenic nerve
Review Panel
Anesthesiology
Submission Type
PMA
Device Classification
Class 3
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code PSR to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:

  • The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
  • The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
  • The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.