SIR-Spheres microspheres
FDA premarket approval P990065/S009 · decided 2017-03-24
Approval details
- PMA number
- P990065
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SIR-Spheres microspheres
- Generic name
- Microspheres radionuclide
- Applicant
- Sirtex Medical, Inc.
- Date received
- 2016-08-08
- Decision date
- 2017-03-24
- Days to decision
- 228 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 Germany Manufacturing GMBH, Industriepark Hoechst, Building G808 65926 Frankfurt am Main Germany.
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