PMA supplement

P830074 S003: GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS

FDA PMA supplement · General Electric Co.

Key facts

Original PMA P830074
Supplement number S003
Trade name GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS
Generic name System, nuclear magnetic resonance imaging
Applicant General Electric Co.
Product code LNH
Received date May 30, 1985
Decision date Oct 30, 1985

At a glance

  • No Expedited review granted
  • No Approval order on file
  • No Summary of safety and effectiveness on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMA supplements

A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.

Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date:

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