|
Device | GALILEO/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 | S017 |
Date Received | 02/10/2003 |
Decision Date | 04/09/2003 |
Withdrawal Date
|
01/31/2008 |
Product Code |
MOU |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO IMPLEMENT A NEW SOFTWARE REVISION, SOFTWARE VERSION 63-0033/M. |