SIR-SPHERES MICROSPHERES
FDA premarket approval P990065/S010 · decided 2017-01-18
Approval details
- PMA number
- P990065
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SIR-SPHERES MICROSPHERES
- Generic name
- Microspheres radionuclide
- Applicant
- Sirtex Medical, Inc.
- Date received
- 2016-12-19
- Decision date
- 2017-01-18
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- NAW
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Woburn, MA
- 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 calc
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