PMA P000052S022
- Device
- GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS
- Applicant
- Guidant Corp.
- PMA number
- P000052
- Supplement
- S022
- Product code
- MOU
- Decision date
- 2003-12-18
- Classification
- Cardiovascular
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- CHANGE IN THE MANUFACTURING PROCESS FOR GUIDANT'S P-32 SOURCE WIRE BY USING AN ALTERNATE NEEDLE COATING PROCESS AND MATERIAL.
Current openFDA PMA Record#
- Device
- GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS
- Applicant
- Guidant Corp.
- PMA number
- P000052
- Supplement
- S022
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2003-12-18
- Decision code
- OK30
- Date received
- 2003-11-18
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE IN THE MANUFACTURING PROCESS FOR GUIDANT'S P-32 SOURCE WIRE BY USING AN ALTERNATE NEEDLE COATING PROCESS AND MATERIAL.