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Omniscience and Omnicarbon Cardiac Valves

FDA PMA

Class III (US FDA PMA)

PMA P830039

by Medical Cv, Inc.

Identity

Trade Name
OMNISCEINCE PROSTHETIC CARDIAC VALVE FDA PMA
Generic Name
HEART-VALVE, MECHANICAL FDA PMA

Identifiers

PMA Number
P830039 FDA PMA
FDA Product Code
LWQ FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APWD FDA PMA

The Omniscience and Omnicarbon Cardiac Valves are mechanical heart-valve prostheses designed for surgical replacement of native cardiac valves. These devices are classified as Class III medical devices under the FDA’s regulatory framework, intended for use in aortic, mitral, or combined aortic and mitral valve replacement procedures.

These valves are supplied as reusable, non-sterile devices and undergo specific cleaning methods during production to remove chlorofluorocarbon solvents. They are available in multiple sizes, including 23 mm, 25 mm, 27 mm, and 29 mm for the aortic model, and are regulated under the FDA’s Premarket Approval (PMA) pathway (PMA P830039). No MRI safety or single-use information is specified in the available data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: OMNISCIENCE AND OMNICARBON CARDIAC VALVES PMA P830039S008 - FDA.report, Clinical experience with the Omnicarbon prosthetic heart valve, OMNICARBON CARDIAC VALVE PROSTHESIS PMA P830039S007 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Medical Cv, Inc.

Sources (1)

  • FDA PMA P830039 24 fields · synced Sep 18, 2026