PMA P000052S025
- Device
- GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM
- Applicant
- Guidant Corp.
- PMA number
- P000052
- Supplement
- S025
- Product code
- MOU
- Decision date
- 2004-06-10
- Classification
- Cardiovascular
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- DISCONTINUE THE PREVENTATIVE MAINTENANCE PROGRAM ON THE HEAD AND BASE COMPONENTS OF THE GALILEO SOURCE DELIVERY UNIT (SDU).
Current openFDA PMA Record#
- Device
- GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM
- Applicant
- Guidant Corp.
- PMA number
- P000052
- Supplement
- S025
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2004-06-10
- Decision code
- OK30
- Date received
- 2004-05-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- DISCONTINUE THE PREVENTATIVE MAINTENANCE PROGRAM ON THE HEAD AND BASE COMPONENTS OF THE GALILEO SOURCE DELIVERY UNIT (SDU).