|
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 | S009 |
Date Received | 07/01/2002 |
Decision Date | 12/10/2002 |
Withdrawal Date
|
01/31/2008 |
Product Code |
MOU |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE CARTRIDGE SHIPPING CONTAINER AND THE ADDITION OF AN ELECTROSTATIC DISCHARGE WARNING LABEL ON THE CARTRIDGE. |