SIR-Spheres Y-90 resin microspheres 510(k) FDA Approval

Device	SIR-Spheres Y-90 resin microspheres
Generic Name	Microspheres Radionuclide
Applicant	Sirtex Medical Pty Ltdshop 6 207 Pacific Highwayst Leonards, New South Wales 2065 PMA NumberP990065 Supplement NumberS012 Date Received03/21/2022 Decision Date04/12/2022 Product Code NAW Advisory Committee Radiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received	2022-03-21
Decision Date	2022-04-12
PMA	P990065
Supplement	S012
Product Code	NAW
Advisory Committee	Radiology
Supplement Type	30-day Notice
Supplement Reason	Process Change - Manufacturer/sterilizer/packager/supplier
Expedited Review	No
Combination Product	No
Applicant Address	Sirtex Medical Pty Ltd shop 6 207 Pacific Highway st Leonards, New South Wales 2065 PMA NumberP990065 Supplement NumberS012 Date Received03/21/2022 Decision Date04/12/2022 Product Code NAW Advisory Committee Radiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For Addition Of An Alternate Qualified Supplier (Niowave, Inc.) For A Critical Raw Material, Y-90 Chloride Solution.

SIR-Spheres Y-90 resin microspheres