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source DB |
source ID
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text
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size
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updated at |
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# proj.
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# Ann.
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updated_at |
| DevicePMAs@therightstef |
P100021_S039 |
Approval for the addition of five (5) short bifurcated stent graft configurations to the endurant ii stent graft system, which are called endurant iis stent grafts (also referred to as endurant iis). |
1.13 KB |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P110023_S012 |
Approval to add the 5f entrust otw delivery system. the device, as modified, will be marketed under the trade name everflex self-expanding peripheral stent with entrust delivery system and is indicate |
451 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P960013_S046 |
Approval for distal tip changes to the tendril st model 1888 lead family. The device, as modified, will be marketed under the trade name tendril sts model 2088tc, and are transvenous steroid eluting |
313 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P970038_S000 |
Approval for the Tandem(R)-R free PSA assay and Tandem(R)-MP free PSA assay. The Tandem(R)-R free PSA Immunoradiometric Assay is an In Vitro device for the quantitative measurement of free prostate s |
1018 Bytes |
2020-03-03 |
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13 |
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0 |
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| DevicePMAs@therightstef |
P010019_S025 |
Approval for a trade name change to the spherical (lotrafilcon a) soft contact lenses with wetting agent (l% copolymer 845) in package saline, and the addition of descriptive text for symbols appearin |
1.55 KB |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P890057_S014 |
Approval for the model 3100b hfov. The device is indicated for use in the ventilatory support and treatment of selected patients 35 kilograms and greater with acute respiratory failure. |
186 Bytes |
2020-03-03 |
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13 |
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0 |
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| DevicePMAs@therightstef |
P980053_S006 |
Approval for a modified bead specification (90-212 um) for the pyrolytic carbon coated zirconium oxide and graphite beads. The device, as modified, will be marketed under the trade name durasphere ex |
342 Bytes |
2020-03-03 |
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13 |
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0 |
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| DevicePMAs@therightstef |
P870015_S030 |
Approval for a transportable configuration of the Medstone STS lithotripter. The devices, as modified, will be marketed under the trade name Medstone STS-T Transportable Lithotripter and is indicated |
334 Bytes |
2020-03-03 |
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13 |
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0 |
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| DevicePMAs@therightstef |
P990081_S003 |
Approval for modifications to the pathway c-erbb-2 primary antibody(clone cb11) which include 1) change the primary antibody from the mouse monoclonal antibody cb11 to the rabbit monoclonal antibody 4 |
1.28 KB |
2020-03-03 |
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13 |
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0 |
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| DevicePMAs@therightstef |
P080008_S002 |
Approval for updating the packaging insert by defining the phrase"instrument of the vidas family" as "instrument of the vidas family: vidas or minividas"and replacing "instruments of the vidas family" |
1.47 KB |
2020-03-03 |
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13 |
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0 |
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