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FDA PMA

Transcatheter septal occluder (atrial)

PMA Number: P200032 · 2026-05-11

ApplicantOcclutech Holding AG
Decision Date2026-05-11
PMA NumberP200032
Product CodeOZG
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Transcatheter septal occluder (atrial) is a medical device manufactured by Occlutech Holding AG. It received FDA Premarket Approval (PMA) on 2026-05-11 under PMA number P200032. The device is classified under FDA product code OZG. 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 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 Transcatheter septal occluder (atrial)?

Transcatheter septal occluder (atrial) is a medical device that received FDA Premarket Approval (PMA) on 2026-05-11. It is manufactured by Occlutech Holding AG. The PMA number is P200032.

When did Transcatheter septal occluder (atrial) receive FDA PMA approval?

Transcatheter septal occluder (atrial) received FDA PMA approval on 2026-05-11, under approval number P200032.

What company makes Transcatheter septal occluder (atrial)?

Transcatheter septal occluder (atrial) is manufactured by Occlutech Holding AG.

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 Transcatheter septal occluder (atrial)?

The FDA product code for Transcatheter septal occluder (atrial) is OZG.

What FDA device class is Transcatheter septal occluder (atrial)?

Transcatheter septal occluder (atrial) 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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