PMA P000052S024
- Device
- GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM
- Applicant
- Guidant Corp.
- PMA number
- P000052
- Supplement
- S024
- Product code
- MOU
- Decision date
- 2004-05-04
- Classification
- Cardiovascular
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- APPROVAL FOR THE ADDITION OF A SECONDARY WIPE STATION TO THE MANUFACTURING PROCESS FOR THE GDT-P32-1 SOURCE WIRES.
Current openFDA PMA Record#
- Device
- GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM
- Applicant
- Guidant Corp.
- PMA number
- P000052
- Supplement
- S024
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2004-05-04
- Decision code
- APPR
- Date received
- 2004-04-06
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF A SECONDARY WIPE STATION TO THE MANUFACTURING PROCESS FOR THE GDT-P32-1 SOURCE WIRES.