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FDA PMA

stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb

PMA Number: P230020 · 2026-05-05

ApplicantNeuros Medical, Inc.
Decision Date2026-05-05
PMA NumberP230020
Product CodeSAZ
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeNE

Device Summary

stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb is a medical device manufactured by Neuros Medical, Inc.. It received FDA Premarket Approval (PMA) on 2026-05-05 under PMA number P230020. The device is classified under FDA product code SAZ. It was reviewed by the NE advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of U. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb?

stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb is a medical device that received FDA Premarket Approval (PMA) on 2026-05-05. It is manufactured by Neuros Medical, Inc.. The PMA number is P230020.

When did stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb receive FDA PMA approval?

stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb received FDA PMA approval on 2026-05-05, under approval number P230020.

What company makes stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb?

stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb is manufactured by Neuros Medical, Inc..

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to provide clinical data proving safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb?

The FDA product code for stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb is SAZ.

What FDA device class is stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb?

stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb is classified as Class III by the FDA.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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