SIR-SPHERE MICROSPHERES
FDA premarket approval P990065/S007 · decided 2014-10-09
Approval details
- PMA number
- P990065
- Supplement
- S007
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SIR-SPHERE MICROSPHERES
- Generic name
- Microspheres radionuclide
- Applicant
- Sirtex Medical, Inc.
- Date received
- 2014-09-09
- Decision date
- 2014-10-09
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- NAW
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- APPROVAL FOR AN OPTIONAL USE OF AN ALTERNATE NON-IONIC SOLUTION 5% DEXTROSE (D5W).
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