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FDA PMA

Unknown Device

PMA Number: P990045 · 2016-06-08

ApplicantDiaSorin, Inc.
Decision Date2016-06-08
PMA NumberP990045
Product Code
Advisory CommitteeMI

Device Summary

This device is a medical device manufactured by DiaSorin, Inc.. It received FDA Premarket Approval (PMA) on 2016-06-08 under PMA number P990045. It was reviewed by the MI advisory panel. 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 this device?

this device is a medical device that received FDA Premarket Approval (PMA) on 2016-06-08. It is manufactured by DiaSorin, Inc.. The PMA number is P990045.

When did this device receive FDA PMA approval?

this device received FDA PMA approval on 2016-06-08, under approval number P990045.

What company makes this device?

this device is manufactured by DiaSorin, 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.

Related Clinical Trials

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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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