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FDA PMA

Acute coronary syndrome event detector

PMA Number: P150009 · 2024-08-14

ApplicantAvertix Medical, Inc.
Decision Date2024-08-14
PMA NumberP150009
Product CodeQBI
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Acute coronary syndrome event detector is the device name listed in this FDA PMA record. The listed applicant is Avertix Medical, Inc.. It received FDA Premarket Approval (PMA) on 2024-08-14 under PMA number P150009. The device is classified under FDA product code QBI. It was reviewed by the CV 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 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 Acute coronary syndrome event detector?

Acute coronary syndrome event detector is a medical device that received FDA Premarket Approval (PMA) on 2024-08-14. The listed applicant is Avertix Medical, Inc.. The PMA number is P150009.

When did Acute coronary syndrome event detector receive FDA PMA approval?

Acute coronary syndrome event detector received FDA PMA approval on 2024-08-14, under PMA number P150009.

Who is the listed applicant for Acute coronary syndrome event detector?

The FDA PMA record lists Avertix Medical, 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 Acute coronary syndrome event detector?

The FDA product code for Acute coronary syndrome event detector is QBI.

What FDA device class is Acute coronary syndrome event detector?

Acute coronary syndrome event detector 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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