|
Device | GALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS |
Generic Name | Intravascular radiation delivery system |
Applicant | GUIDANT CORP. 26531 YNEZ RD. TEMECULA, CA 92591-4630 |
PMA Number | P000052 |
Supplement Number | S019 |
Date Received | 06/30/2003 |
Decision Date | 07/24/2003 |
Withdrawal Date
|
01/31/2008 |
Product Code |
MOU |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |