age_PMA_annotations  

Documents (2,258) JSON TSV

source DB source ID text size updated at # proj. # Ann. updated_at
DevicePMAs@therightstef P000040_S004 Approval for updated labeling that reflects the 2 and 3 year patient follow-up data. The device, as modified, will be marketed under the trade name htz system and is indicated for ablation of the end 354 Bytes 2020-03-03 13 0
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DevicePMAs@therightstef P860003_S031 Approval for engineering changes to the UVAR(R) Photopheresis System including the following: 1) Replacing the obsolete Haemotronics centrifuge assembly with the current generation Haemotronics centr 949 Bytes 2020-03-03 13 0
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DevicePMAs@therightstef P010019_S021 Approval for a trade name change to the (lotrafilcon b) soft contact lenses with wetting agent in package saline. The device, as modified, will be marketed under the trade name ciba vision air optix 1.76 KB 2020-03-03 11 0
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DevicePMAs@therightstef P830045_S094 Approval for modifications to the epic ii/epic ii+ and epic ii hf devices. The modifications include adding a vibratory patient notifier; modifying the electrogram morphology algorithm; modifying the 1.6 KB 2020-03-03 11 0
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DevicePMAs@therightstef P140026_S000 Approval for the enroute transcarotid stent system. this device is indicated for use in conjunction with the enroute transcarotid neuroprotection system (nps) for the treatment of patients at high ris 780 Bytes 2020-03-03 13 0
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DevicePMAs@therightstef P110008_S000 Approval for the coflex interlaminar technology. This device is indicated for use in one- or two-level lumbar stenosis from l1- l5 in skeletally mature patients with at least moderate impairment in f 599 Bytes 2020-03-03 13 0
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DevicePMAs@therightstef P100022_S020 Approval for the Zilver PTX Drug-Eluting Peripheral Stent is indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the a 340 Bytes 2020-03-03 13 0
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DevicePMAs@therightstef P160013_S000 Approval for the OCS Lung System, indicated for the preservation of standard criteria donor lungs in a near physiologic, ventilated, and perfused state for double lung transplantation. 184 Bytes 2020-03-03 13 0
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DevicePMAs@therightstef P010012_S031 Approval for the addition of wandless telemetry to your currently market-approved crt-d devices that will allow communication with the programmer at an increased distance. the device, as modified, wil 552 Bytes 2020-03-03 11 0
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DevicePMAs@therightstef P020033_S000 Approval for the independence ibot 3000 mobility system. The device is indicated for individuals who have mobility impairments and the use of at least one upper extremity. The device is intended to 632 Bytes 2020-03-03 13 0
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