|
Device | 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 | S021 |
Date Received | 09/30/2003 |
Decision Date | 03/04/2004 |
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 CHANGE TO THE P-32 SOURCE WIRE MANUFACTURING PROCESS TO INCORPORATE AN AUTOMATED SOURCE WIRE ASSEMBLY STATION (SWAS) AS AN ALTERNATE PROCESS FOR FINAL ASSEMBLY OF P-32 SOURCE WIRES. |