- Device
- SIR-Spheres microspheres
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P990065
- Supplement
- S009
- Product code
- NAW
- Generic name
- Microspheres radionuclide
- Decision date
- 2017-03-24
- Decision code
- APPR
- Date received
- 2016-08-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Sirtex Germany Manufacturing GMBH, Industriepark Hoechst, Building G808 65926 Frankfurt am Main Germany.