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Infusaid Implantable Infusion Pump Model-100, 200, 4

FDA PMA

Class III (US FDA PMA)

PMA P800036

by Intera Oncology

Identity

Trade Name
INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4 FDA PMA
Generic Name
Pump, infusion, implanted, programmable FDA PMA

Identifiers

PMA Number
P800036 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
PMA Supplement
S004 FDA PMA

The InfusAid Implantable Infusion Pump Model 100, 200, 4 is a programmable, implanted infusion pump designed for continuous or intermittent delivery of fluids, such as chemotherapy or pain management medications, directly into the body. It operates autonomously once implanted, allowing precise dosing and timing without external intervention, and is classified as a Class III medical device under FDA regulations.

This device is intended for surgical implantation under sterile conditions and is intended for single-use. It is regulated under an FDA Premarket Approval (PMA) application (P800036) and is supplied in sterile packaging. The pump’s programmable features enable clinicians to adjust delivery parameters, and its design adheres to MRI safety standards where applicable. Models 100, 200, and 4 are differentiated by specific functional or capacity specifications, as outlined in the original approval documentation.

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 P800036 24 fields · synced Sep 18, 2026