PMA P990065S001
- Device
- SIR-SPHERES
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P990065
- Supplement
- S001
- Product code
- NAW
- Decision date
- 2003-04-24
- Generic name
- Microspheres radionuclide
- Approval order statement
- APPROVAL FOR ADDITIONAL WARNING ON THE LABEL.
Current openFDA PMA Record#
- Device
- SIR-SPHERES
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P990065
- Supplement
- S001
- Product code
- NAW
- Generic name
- Microspheres radionuclide
- Decision date
- 2003-04-24
- Decision code
- APPR
- Date received
- 2003-03-25
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR ADDITIONAL WARNING ON THE LABEL.