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FDA PMA

Unknown Device

PMA Number: P140020 · 2024-10-04

ApplicantMyriad Genetic Laboratories
Decision Date2024-10-04
PMA NumberP140020
Product Code
Advisory CommitteePA

Device Summary

This device is the device name listed in this FDA PMA record. The listed applicant is Myriad Genetic Laboratories. It received FDA Premarket Approval (PMA) on 2024-10-04 under PMA number P140020. It was reviewed by the PA advisory panel. 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 this device?

this device is a medical device that received FDA Premarket Approval (PMA) on 2024-10-04. The listed applicant is Myriad Genetic Laboratories. The PMA number is P140020.

When did this device receive FDA PMA approval?

this device received FDA PMA approval on 2024-10-04, under PMA number P140020.

Who is the listed applicant for this device?

The FDA PMA record lists Myriad Genetic Laboratories 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.

Other records listing Myriad Genetic Laboratories as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P190014Cancer-related germline gene mutation detection system

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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