| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | SIR-SPHERES MICROSPHERES |
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| Generic Name | Microspheres radionuclide |
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| Applicant | Sirtex Medical Pty Ltd
Shop 6 207 Pacific Highway
St Leonards, New South Wales 2065 |
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| PMA Number | P990065 |
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| Supplement Number | S010 |
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| Date Received | 12/19/2016 |
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| Decision Date | 01/18/2017 |
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| Product Code |
NAW |
| Advisory Committee |
Radiology |
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| Supplement Type | Special (Immediate Track) |
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| Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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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. |
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