Last synced on 2 May 2025 at 11:05 pm

Transvenous Temporary Phrenic Nerve Stimulator

Page Type
Product Code
Definition
The device is intended to be implanted transvenously to stimulate the phrenic nerves to improve weaning from a mechanical ventilator. The device is temporary (<30 days) and is for use only in patients 18 years of age or older.
Physical State
The device consists of a neurostimulation catheter and a console to control the stimulation delivery.
Technical Method
A neurostimulation catheter is inserted in the jugular vein or subclavian vein and passed through the superior vena cava, overlaying the left and right phrenic nerves. The system detects a breath, either through manual activation or connection to the breathing circuit, and transmits electrical stimulation to initiate diaphragmatic contractions.
Target Area
Diaphragm, phrenic nerves.
Review Panel
Anesthesiology
Submission Type
PMA
Device Classification
Class 3
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code SDL 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.

Transvenous Temporary Phrenic Nerve Stimulator

Page Type
Product Code
Definition
The device is intended to be implanted transvenously to stimulate the phrenic nerves to improve weaning from a mechanical ventilator. The device is temporary (<30 days) and is for use only in patients 18 years of age or older.
Physical State
The device consists of a neurostimulation catheter and a console to control the stimulation delivery.
Technical Method
A neurostimulation catheter is inserted in the jugular vein or subclavian vein and passed through the superior vena cava, overlaying the left and right phrenic nerves. The system detects a breath, either through manual activation or connection to the breathing circuit, and transmits electrical stimulation to initiate diaphragmatic contractions.
Target Area
Diaphragm, phrenic nerves.
Review Panel
Anesthesiology
Submission Type
PMA
Device Classification
Class 3
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code SDL 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.