|
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 | S002 |
Date Received | 11/27/2001 |
Decision Date | 04/19/2002 |
Withdrawal Date
|
01/31/2008 |
Product Code |
MOU |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE. THE POST-APPROVAL STUDY HAS BEEN SUBMITTED TO COMPLY WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE NOVEMBER 2, 2001 APPROVAL ORDER FOR P000052. |