|
Device | GALILEO(TM) INTRAVASCULAR RADIOTHERAPY SYSTEM |
Generic Name | Intravascular radiation delivery system |
Applicant | GUIDANT CORP. 26531 YNEZ RD. TEMECULA, CA 92591-4630 |
PMA Number | P000052 |
Supplement Number | S001 |
Date Received | 11/20/2001 |
Decision Date | 12/18/2001 |
Withdrawal Date
|
01/31/2008 |
Product Code |
MOU |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MODIFICATION OF A MANUFACTURING PROCESS, INCORPORATING ADDITIONAL ENVIRONMENTAL CONTROLS, FOR THE GDT-P32-2 (27 MM) SOURCE WIRE COMPONENT OF THE GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM. |