PMA P000052S023

Device: GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM
Applicant: Guidant Corp.
PMA number: P000052
Supplement: S023
Product code: MOU
Decision date: 2004-03-16
Classification: Cardiovascular
Generic name: Intravascular radiation delivery system
Approval order statement: APPROVAL TO IMPLEMENT A NEW SOFTWARE REVISION, VERSION 63-033/N. THE SOFTWARE WAS REVISED TO INCREASE THE DISTAL STOP FORCE OF THE ACTIVE SOURCE WIRE.

Current openFDA PMA Record#

Device: GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM
Applicant: Guidant Corp.
PMA number: P000052
Supplement: S023
Product code: MOU
Generic name: Intravascular radiation delivery system
Decision date: 2004-03-16
Decision code: APPR
Date received: 2004-01-09
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO IMPLEMENT A NEW SOFTWARE REVISION, VERSION 63-033/N. THE SOFTWARE WAS REVISED TO INCREASE THE DISTAL STOP FORCE OF THE ACTIVE SOURCE WIRE.