PMA P000052S017
- Device
- GALILEO/GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS
- Applicant
- Guidant Corp.
- PMA number
- P000052
- Supplement
- S017
- Product code
- MOU
- Decision date
- 2003-04-09
- Classification
- Cardiovascular
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- APPROVAL TO IMPLEMENT A NEW SOFTWARE REVISION, SOFTWARE VERSION 63-0033/M.
Current openFDA PMA Record#
- Device
- GALILEO/GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS
- Applicant
- Guidant Corp.
- PMA number
- P000052
- Supplement
- S017
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2003-04-09
- Decision code
- APPR
- Date received
- 2003-02-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO IMPLEMENT A NEW SOFTWARE REVISION, SOFTWARE VERSION 63-0033/M.