PMA P000052S020
- Device
- GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM
- Applicant
- Guidant Corp.
- PMA number
- P000052
- Supplement
- S020
- Product code
- MOU
- Decision date
- 2003-09-03
- Classification
- Cardiovascular
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- APPROVAL FOR LABELING CHANGES AS A SHORT TERM CORRECTIVE ACTION TO A COMPLAINT INVESTIGATION.
Current openFDA PMA Record#
- Device
- GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM
- Applicant
- Guidant Corp.
- PMA number
- P000052
- Supplement
- S020
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2003-09-03
- Decision code
- APPR
- Date received
- 2003-08-13
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES AS A SHORT TERM CORRECTIVE ACTION TO A COMPLAINT INVESTIGATION.