|
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 | S010 |
Date Received | 07/05/2002 |
Decision Date | 08/02/2002 |
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 AMENDING IMPLEMENTATION OF MANUFACTURING CHANGES DESCRIBED IN P000052/S007, APPROVED APRIL 17, 2002 AND ADDING A VERIFICATION STEP TO THE PREVENTIVE MAINTENANCE CHECKLIST FOR THE GALILEO SOURCE DELIVERY UNIT. |