Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030198397

FEI Number

3030198397

Entity Name

Infusyn Therapeutics

City/State/Country

Hackettstown, NJ, US

Establishment Address

121 Shelley Drive, Suite 2H, Hackettstown, NJ 07840, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Infusyn Therapeutics (Owner Number: 10089601)

Owner / Operator Contact Address

121 Shelley Drive, Suite 2H, Hackettstown, NJ 07840, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P080012

All Registered Proprietary Names

Prometra Programmable Infusion Pump System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LKK	Pump, Infusion, Implanted, Programmable	Unknown	Class 3	N/A	2023-12-21

Official Correspondent

Whitney Torning

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Infusyn Therapeutics

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2007	Medtronic Neuromodulation	3	Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.

Similar Registrations

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3003174284	NextPhase Medical Devices, LLC	MANSFIELD, MA, US
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3004209178	MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS	Juncos, PR, US
2523676	B. BRAUN US DEVICE MANUFACTURING LLC	ALLENTOWN, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030198397. Last updated year: 2026. Please use registration number 3030198397 when referencing this establishment in official correspondence.