PMA P000052S019

Device: GALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS
Applicant: Guidant Corp.
PMA number: P000052
Supplement: S019
Product code: MOU
Decision date: 2003-07-24
Classification: Cardiovascular
Generic name: Intravascular radiation delivery system
Approval order statement: APPROVAL OF THE FOLLOWING CHANGES TO THE LABELING: 1) ADDING A WARNING STATEMENT ALERTING USERS TO THE POTENTIAL FOR A RADIATION OVERDOSE IF AN INTERRUPTED TREATMENT IS NOT RESUMED APPROPRIATELY. 2) MODIFYING THE EMERGENCY RESPONSE PROCEDURES TO ASSIST USERS TO RETRACT THE ACTIVE WIRE IN THE MOST EXPEDITIOUS MANNER WHILE MAINTAINING SAFETY OF THE PATIENT AND THE RADIATION PERSONNEL INVOLVED IN CASE OF AN EMERGENCY.

Current openFDA PMA Record#

Device: GALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS
Applicant: Guidant Corp.
PMA number: P000052
Supplement: S019
Product code: MOU
Generic name: Intravascular radiation delivery system
Decision date: 2003-07-24
Decision code: APPR
Date received: 2003-06-30
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL OF THE FOLLOWING CHANGES TO THE LABELING: 1) ADDING A WARNING STATEMENT ALERTING USERS TO THE POTENTIAL FOR A RADIATION OVERDOSE IF AN INTERRUPTED TREATMENT IS NOT RESUMED APPROPRIATELY. 2) MODIFYING THE EMERGENCY RESPONSE PROCEDURES TO ASSIST USERS TO RETRACT THE ACTIVE WIRE IN THE MOST EXPEDITIOUS MANNER WHILE MAINTAINING SAFETY OF THE PATIENT AND THE RADIATION PERSONNEL INVOLVED IN CASE OF AN EMERGENCY.