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Medstream Programmable Infusion System

FDA PMA

Class III (US FDA PMA)

PMA P890055

by Intera Oncology

Identity

Trade Name
MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEM FDA PMA
Generic Name
Pump, infusion, implanted, programmable FDA PMA

Identifiers

PMA Number
P890055 FDA PMA
FDA Product Code
LKK FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
General Hospital FDA PMA
FDA Decision
APPR Approved FDA PMA

The Medstream Programmable Infusion System is an implanted, programmable infusion pump designed for constant flow delivery of therapeutic agents. It is classified as a Class III device under the generic name 'Pump, infusion, implanted, programmable'.

This system is supplied as an implantable device intended for long-term use in a hospital or clinical setting. It received FDA Premarket Approval (PMA) under P890055 on March 11, 1996, and is manufactured by Intera Oncology in Newton, MA. The device is not described as sterile, single-use, or MRI-safe in the provided data, and no storage conditions or sizes are specified.

Frequently asked questions

What type of device is the Medstream Programmable Infusion System?

The Medstream Programmable Infusion System is an implanted, programmable infusion pump, as defined by its generic name and FDA classification under device class 3 for 'Pump, infusion, implanted, programmable'.

What regulatory authorization does the Medstream Programmable Infusion System have?

The device has FDA Premarket Approval (PMA) under application number P890055, which was approved on March 11, 1996, as indicated by the decision code APPR and decision date in the data.

Who manufactures the Medstream Programmable Infusion System and where are they located?

The Medstream Programmable Infusion System is manufactured by Intera Oncology, located at 180 Wells Ave., Suite 300a, Newton, MA 02459, as stated in the manufacturer and address fields.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Intera Oncology

Sources (1)

  • FDA PMA P890055 24 fields · synced Sep 18, 2026