SIR-SPHERES
FDA premarket approval P990065 · decided 2002-03-05
Approval details
- PMA number
- P990065
- Trade name
- SIR-SPHERES
- Generic name
- Microspheres radionuclide
- Applicant
- Sirtex Medical, Inc.
- Date received
- 1999-10-25
- Decision date
- 2002-03-05
- Days to decision
- 862 days
- Decision code
- APPR
- Product code
- NAW
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- APPROVAL FOR SIR-SPHERES. THE DEVICE IS INDICATED FOR THE TREATMENT OF UNRESECTABLE METASTATIC LIVER TUMORS FROM PRIMARY COLORECTAL CANCER WITH ADJUVANT INTRA-HEPATIC ARTERY CHEMOTHERAPY (IHAC) OF FUDR (FLOXURIDINE).
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