SIR-SPHERES
FDA premarket approval P990065/S004 · decided 2008-01-18
Approval details
- PMA number
- P990065
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- SIR-SPHERES
- Generic name
- Microspheres radionuclide
- Applicant
- Sirtex Medical, Inc.
- Date received
- 2006-05-15
- Decision date
- 2008-01-18
- Days to decision
- 613 days
- Decision code
- APPR
- Product code
- NAW
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- APPROVAL FOR A MANUFACTURING AND STERILIZATION SITE LOCATED IN WILMINGTON, MASSACHUSETTS.
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