age_PMA_annotations  

Documents (2,258) JSON TSV

source DB source ID text size updated at # proj. # Ann. updated_at
DevicePMAs@therightstef P030026_S016 Approval for revision of the intended use to include use of the vitros 5600integrated system and vitros 3600 immunodiagnostic system with the anti-hbc igm assay. The device, as modified, will be mark 1.59 KB 2020-03-03 11 0
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DevicePMAs@therightstef P010002_S000 Approval for the indermil tissue adhesive. The device is indicated for the closure of topical skin incisions including laparoscopic incisions, and trauma-induced lacerations in areas of low skin tens 368 Bytes 2020-03-03 13 0
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DevicePMAs@therightstef P980023_S027 Approval for leads based on the linox sd and linox td leads with one shock coil instead of two shock coils. The devices, as modified, will be marketed under the trade names linox s implantable cardio 530 Bytes 2020-03-03 11 0
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DevicePMAs@therightstef P980001_S000 approval for the NIR ON(TM) Ranger(TM) and NIR ON(TM) Ranger(TM) w/SOX(TM) Premounted Stent Systems. The device is indicated for improving coronary luminal diamter in the following patient subsets: 716 Bytes 2020-03-03 11 0
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DevicePMAs@therightstef P910065_S001 Approval for the AIA-PACK PA. The device is designed for in vitro diagnostic use only for the quantitative measurement of Prostate Specific Antigen (PSA) in human serum on TOSOH AIA System analyzers. 614 Bytes 2020-03-03 13 0
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DevicePMAs@therightstef P970020_S042 Approval for the multi-link rx and otw zeta coronary stent systems. The devices are indicated for improving coronary lumen diameter in the following: 1) patients with symptomatic ischemic heart dise 1.07 KB 2020-03-03 11 0
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DevicePMAs@therightstef P950037_S007 Approval for a VDDR single pass lead system. The device is indicated for the following: The Actros SLR+ and Kairos SL pacemakers are intended to provide VDD or VDDR pacing for patients with a health 1 KB 2020-03-03 11 0
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DevicePMAs@therightstef P140005_S000 Approval for genvisc 850. this device is indicated for or the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic t 251 Bytes 2020-03-03 13 0
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DevicePMAs@therightstef P920047_S028 Approval for modification to the hardware, software, and new accessories of the ept-1000 series of cardiac ablation systems. The device, as modified, will be marketed under the trade name maestro 300 735 Bytes 2020-03-03 11 0
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DevicePMAs@therightstef P030004_S000 Approval for the onyx liquid embolic system (les). The device is indicated for presurgical embolization of brain arteriovenous malformations. 142 Bytes 2020-03-03 13 0
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