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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 |
P110003_S000 |
Approval for the legoo. This device is indicated for temporary endovascular occlusion of blood vessels below the neck up to 4 mm in diameter. |
142 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P990055_S002 |
Approval to add a microtiter plate capture system to the current device. The device, as modified, will be marketed under the trade name oncogene science complexed psa microtiter elisa and is indicate |
952 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P950022_S041 |
Approval to modify the shock coil on the riata st optim and riata sts optim leads and to add two new passive lead models. The devices, as modified, will be marketed under the trade name riata st opti |
558 Bytes |
2020-03-03 |
|
11 |
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0 |
-
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| DevicePMAs@therightstef |
P140016_S000 |
Approval for the zenith alpha thoracic endovascular graft. this device is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dis |
609 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P100030_S000 |
Approval for the arterx surgical sealant. This device is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage. |
178 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P950037_S001 |
Approval for a capacitive sensor, integrated circuit change and its supporting circuityr, hybrid circuit modification, battery change, pacemaker housing change, modified header, PMS 1000 C programmer, |
1.37 KB |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P150013_S001 |
Approval for 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 protein in formalin-fixed, paraf |
952 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P980016_S033 |
Approval for the model 2490d/e carelink monitors and the server-based model 2491 device data management software application (ddma) which are indicated for use by the patient to interrogate their impl |
315 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P020045_S006 |
Approval for the 9f freezor max surgical cardiac cryoablation device, a modification to the freezor xtra cardiac cryoablation system previously approved under p020045/s005. The device is indicated fo |
301 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P950037_S030 |
Approval for a modified philos dr pacing system. The device, as modified, will be marketed under the trade name philos dr acc pacing system and programmer software version b-kac. v. u/1 and is indica |
1.2 KB |
2020-03-03 |
|
11 |
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0 |
-
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