|
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 | S008 |
Date Received | 03/29/2002 |
Decision Date | 08/09/2002 |
Withdrawal Date
|
01/31/2008 |
Product Code |
MOU |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING CHANGE, USING AN AUTOMATED SOURCE WIRE QUALITY CONTROL MACHINE AS AN ALTERNATIVE TO MANUAL SOURCE WIRE FINAL TESTING AND INSPECTION. |