PMA P000052S021

Device: GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS
Applicant: Guidant Corp.
PMA number: P000052
Supplement: S021
Product code: MOU
Decision date: 2004-03-04
Classification: Cardiovascular
Generic name: Intravascular radiation delivery system
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.

Current openFDA PMA Record#

Device: GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS
Applicant: Guidant Corp.
PMA number: P000052
Supplement: S021
Product code: MOU
Generic name: Intravascular radiation delivery system
Decision date: 2004-03-04
Decision code: APPR
Date received: 2003-09-30
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.