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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 |
P040027_S000 |
Approval for the gore viatorr tips endoprosthesis. The device is indicated for use in de novo and revision treatment of portal hypertension and its complications such as variceal bleeding, gastropath |
239 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P140033_S000 |
Approval for the MR Conditional Pacemaker System (which includes the Assurity MRI (Models PM 1272, PM 2272) and Endurity MRI (Models PM 1172, PM 2172) pacemakers, Tendril MRI Lead (Model LPA 1200M), |
2.98 KB |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P950014_S022 |
Approval for design changes to include changing the contacts on the internal wiring from tin to gold and a modification to the software to include an additional alarm. The device, as modified, will b |
324 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P930034_S013 |
Approval for the svs apex plus excimer laser workstation and emphasis(r) "m" discs (m00-m09) these devices are indicated to perform lasik: 1) for the reduction or elimination of myopia ranging from 0 |
420 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P150013_S016 |
Approval for the PD-L1 IHC 22C3 pharmDx. PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using monoclonal mouse anti-PD-L1, Clone 22C3 intended for use in the detection of PD-L1 pro |
2.28 KB |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P010032_S003 |
Approval for the model 3811 paindoc computerized support system, version 2.01 for use with the genesis model 3850 patient programmer which are indicated as an aid in the management of chronic intracta |
361 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P950005_S041 |
Approval for modified catheter designs to the 7fr celsius and 7fr ez steer ds catheters to create the 7.5fr 8 mm celsius fltr catheters. the changes being approved are the increased distal profile, la |
729 Bytes |
2020-03-03 |
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11 |
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3 |
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| DevicePMAs@therightstef |
P840001_S065 |
Approval for the model 3898 pisces-octad lead and the model 7471 octapolar extension which are indicated as an aid in the management of chronic, intractable pain of the trunk or limbs. |
184 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P090022_S000 |
Approval for the softec hd posterior chamber intraocular lens (pciol). The device is indicated for the replacement of the human crystalline lens following phacoemulsification cataract removal in adul |
273 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P140032_S000 |
Approval for the Implantable System for Remodulin. This device is indicated for adult patients with Class I, II and III pulmonary arterial hypertension (PAH) receiving intravenous delivery of Remoduli |
202 Bytes |
2020-03-03 |
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11 |
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0 |
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