PMA P990065S007
- Device
- SIR-SPHERE MICROSPHERES
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P990065
- Supplement
- S007
- Product code
- NAW
- Decision date
- 2014-10-09
- Generic name
- Microspheres radionuclide
- Approval order statement
- APPROVAL FOR AN OPTIONAL USE OF AN ALTERNATE NON-IONIC SOLUTION 5% DEXTROSE (D5W).
Current openFDA PMA Record#
- Device
- SIR-SPHERE MICROSPHERES
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P990065
- Supplement
- S007
- Product code
- NAW
- Generic name
- Microspheres radionuclide
- Decision date
- 2014-10-09
- Decision code
- APPR
- Date received
- 2014-09-09
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR AN OPTIONAL USE OF AN ALTERNATE NON-IONIC SOLUTION 5% DEXTROSE (D5W).