Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035553858

FEI Number

3035553858

Entity Name

PGX PLATINUM HEALTH

City/State/Country

Carle Place, NY, US

Establishment Address

241 Rushmore Ave, Carle Place, NY 11514, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

PGX Platinum Health (Owner Number: 10092627)

Owner / Operator Contact Address

241 Rushmore Avenue, Huntington, NY 11743, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cardiaguard

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DTF	Tools, Pacemaker Service	Cardiovascular	Class 1	870.3730	2025-01-29

Official Correspondent

Michael Chalavoutis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PGX Platinum Health

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
9617601	Medtronic Mexico S. de R.L. de CV	Tijuana Baja California, MX
2649622	MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA	Villalba, PR, US
1520597	CRESCENT MFG. CO.	FREMONT, OH, US
3044467533	TAROMED INC	Los Angeles, CA, US
3008775647	SHAKAM, LLC	Columbus, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035553858. Last updated year: 2026. Please use registration number 3035553858 when referencing this establishment in official correspondence.