PMA P990065S010

Device: SIR-SPHERES MICROSPHERES
Applicant: Sirtex Medical, Inc.
PMA number: P990065
Supplement: S010
Product code: NAW
Decision date: 2017-01-18
Generic name: Microspheres radionuclide
Approval order statement: Approval for changes in device package insert with insertion of BSA model to replace the current empirical model for calculation of individual required activity dose, change of lung shunt fraction to total lung dose, less than 30 Gy to apply in the dose calculation, re-define the Radio-Embolization Induced Liver Disease (REILD) and addition of dose reduction guidance in REILD, addition of guidance of lobar therapy using BSA model, and deletion of empirical model and partition model for dose calculation.

Current openFDA PMA Record#

Device: SIR-SPHERES MICROSPHERES
Applicant: Sirtex Medical, Inc.
PMA number: P990065
Supplement: S010
Product code: NAW
Generic name: Microspheres radionuclide
Decision date: 2017-01-18
Decision code: APPR
Date received: 2016-12-19
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for changes in device package insert with insertion of BSA model to replace the current empirical model for calculation of individual required activity dose, change of lung shunt fraction to total lung dose, less than 30 Gy to apply in the dose calculation, re-define the Radio-Embolization Induced Liver Disease (REILD) and addition of dose reduction guidance in REILD, addition of guidance of lobar therapy using BSA model, and deletion of empirical model and partition model for dose calculation.