Data / Medical devices / United States / Infusyn Therapeutics

Infusyn Therapeutics: FDA-registered device maker in Hackettstown, NJ, United States, 1 PMA approval

Infusyn Therapeutics is registered with the FDA (registration 3030198397) in Hackettstown, NJ, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated February 7, 2012. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number

3030198397

Address

121 Shelley Drive, Suite 2H, Hackettstown, NJ, United States, 07840

Owner or operator

Infusyn Therapeutics (10089601)

Roles

Complaint file establishment, Specification developer

First device listed

December 21, 2023

Registered through

2026

Brand names listed

Prometra Programmable Infusion Pump System

Devices it lists

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Compare with other makers

• All makers of Pump, Infusion, Implanted, Programmable

Updated June 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.