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PMA_Manual  

Documents (2,258) JSON TSV

source DB source ID text size updated at # proj. # Ann. updated_at
DevicePMAs@therightstef P840001_S219 Approval for of the medtronic surescantm mri implantable neurostimulation system, which consists of 1.65 KB 2020-03-03 11 29
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DevicePMAs@therightstef P040004_S010 Approval for claims to test neonate and pediatric populations with the fda approved advia centaur hb 1.9 KB 2020-03-03 11 20
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DevicePMAs@therightstef P980016_S668 Approval for an update to the indications for use to include pacing at the bundle of His. The device 459 Bytes 2020-03-03 10 14
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DevicePMAs@therightstef P120014_S000 Approval for the thxid braf kit for use on the abi 7500 fast dx real-time pcr instrument. this devic 705 Bytes 2020-03-03 13 12
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DevicePMAs@therightstef P170037_S000 Approval for the Sangia Total PSA Test. The Sangia Total PSA Test is an immunoassay indicated to qu 513 Bytes 2020-03-03 13 12
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DevicePMAs@therightstef P000020_S004 Approval for the addition of another ablation catheter model to the existing stinger(tm) product lin 391 Bytes 2020-03-03 11 9
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DevicePMAs@therightstef P120019_S019 Approval for the cobas EGFR Mutation Test v2. The device is a real-time PCR test for the qualitativ 2.41 KB 2020-03-03 13 8
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DevicePMAs@therightstef P160052_S000 Approval for the PartoSure test. The device is a rapid, qualitative test for detecting the presence 564 Bytes 2020-03-03 13 7
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DevicePMAs@therightstef P120021_S000 Approval for the AMPLATZER PFO Occluder. The device is indicated for percutaneous transcatheter clo 438 Bytes 2020-03-03 13 7
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DevicePMAs@therightstef P100031_S000 Approval for the elecsys anti-hbc immunoassay & elecsys precicontrol anti-hbc for use on the modular 1006 Bytes 2020-03-03 11 7
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