SIR-SPHERES
FDA premarket approval P990065/S001 · decided 2003-04-24
Approval details
- PMA number
- P990065
- Supplement
- S001
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SIR-SPHERES
- Generic name
- Microspheres radionuclide
- Applicant
- Sirtex Medical, Inc.
- Date received
- 2003-03-25
- Decision date
- 2003-04-24
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- NAW
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- APPROVAL FOR ADDITIONAL WARNING ON THE LABEL.
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