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Galileo Intravascular Radiotherapy System

by Guidant Corp. PMA

Withdrawn United States

PMA P000052

Regulatory status

as of 29 Oct 2026

Withdrawn since 2 Nov 2001. The authorization below is no longer in force.

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP000052 Date2 Nov 2001Approval withdrawnStatusWithdrawn

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Withdrawn

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

PMA

Generic Name
Intravascular radiation delivery system
PMA Number
FDA Product Code
MOU
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APWD Approval withdrawn

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