|
Device | GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM |
Generic Name | Intravascular radiation delivery system |
Applicant | GUIDANT CORP. 26531 YNEZ RD. TEMECULA, CA 92591-4630 |
PMA Number | P000052 |
Supplement Number | S006 |
Date Received | 02/22/2002 |
Decision Date | 08/02/2002 |
Withdrawal Date
|
01/31/2008 |
Product Code |
MOU |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO COMPONENTS USED IN THE SDU HEAD AND CARTRIDGE OF THE GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM. THE DEVICE MODIFICATIONS INCLUDE CHANGES TO THE EMERGENCY RETRACT SYSTEM, THE STOP COLLAR/WIRE DRIVES AND THE CARTRIDGE LATCHING MECHANISM. |