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FDA PMA

implanted diaphragmatic/phrenic nerve Stimulator

PMA Number: P860026 · 2019-11-04

ApplicantAvery Biomedical Devices, Inc.
Decision Date2019-11-04
PMA NumberP860026
Product CodeGZE
Device ClassClass 3
Medical SpecialtyN
Regulation Number21 CFR 8
Advisory CommitteeAN

Device Summary

implanted diaphragmatic/phrenic nerve Stimulator is the device name listed in this FDA PMA record. The listed applicant is Avery Biomedical Devices, Inc.. It received FDA Premarket Approval (PMA) on 2019-11-04 under PMA number P860026. The device is classified under FDA product code GZE. It was reviewed by the AN 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 N. It is regulated under 21 CFR Part 8. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. 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 implanted diaphragmatic/phrenic nerve Stimulator?

implanted diaphragmatic/phrenic nerve Stimulator is a medical device that received FDA Premarket Approval (PMA) on 2019-11-04. The listed applicant is Avery Biomedical Devices, Inc.. The PMA number is P860026.

When did implanted diaphragmatic/phrenic nerve Stimulator receive FDA PMA approval?

implanted diaphragmatic/phrenic nerve Stimulator received FDA PMA approval on 2019-11-04, under PMA number P860026.

Who is the listed applicant for implanted diaphragmatic/phrenic nerve Stimulator?

The FDA PMA record lists Avery Biomedical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for implanted diaphragmatic/phrenic nerve Stimulator?

The FDA product code for implanted diaphragmatic/phrenic nerve Stimulator is GZE.

What FDA device class is implanted diaphragmatic/phrenic nerve Stimulator?

implanted diaphragmatic/phrenic nerve Stimulator is classified as Class III by the FDA.

Official Source

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

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