SIR-SPHERES
FDA premarket approval P990065/S006 · decided 2012-07-17
Approval details
- PMA number
- P990065
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SIR-SPHERES
- Generic name
- Microspheres radionuclide
- Applicant
- Sirtex Medical, Inc.
- Date received
- 2011-09-19
- Decision date
- 2012-07-17
- Days to decision
- 302 days
- Decision code
- APPR
- Product code
- NAW
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SIRTEX SINGAPORE PTE LTD. IN SINGAPORE.
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