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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 |
P020041_S000 |
Approval for the femcap barrier contraceptive. The femcap is indicated for use by women of childbearing age who desire to prevent or postpone pregnancy. |
153 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P910023_S061 |
Approval for a downsized version of the photon udr/vr device. The device, as modified, will be marketed under the trade name st. jude medical epic vr/dr implantable cardioverter defibrillators (model |
380 Bytes |
2020-03-03 |
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10 |
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0 |
-
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| DevicePMAs@therightstef |
P910077_S026 |
Approva for a switchable ECG cable that allows the clinician to display and record ECG signals from seven different vectors (leads) without moving the ECG electrodes that are attached to the patient. |
401 Bytes |
2020-03-03 |
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10 |
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0 |
-
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| DevicePMAs@therightstef |
P910073_S039 |
Approval for modified active fixation defibrillation leads. The device, as modified, will be marketed under the trade names endotak reliance and reliance/s leads and is indicated for pacing and rate- |
324 Bytes |
2020-03-03 |
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10 |
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0 |
-
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| DevicePMAs@therightstef |
P980016_S037 |
Approval to modify the marquis vr and dr systems to provide increased energy output (35j). The devices will be used with the following application software versions: model 9978 version 1.0 applicatio |
711 Bytes |
2020-03-03 |
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10 |
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0 |
-
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| DevicePMAs@therightstef |
P910023_S057 |
Approval for the identity pulse generator model sr 5172. The device is indicated in the following permanent conditions, when associated with symptoms including, but not limited to: syncope, presyncop |
1.04 KB |
2020-03-03 |
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9 |
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0 |
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| DevicePMAs@therightstef |
P980016_S046 |
Approval for the medtronic entrust models d153atg, d153drg, d153vrc, d154atg, d154drg, d154vrc, medtronic model 9987 application software and the medtronic model 2696 incheck patient assistant are ind |
1.91 KB |
2020-03-03 |
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9 |
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0 |
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| DevicePMAs@therightstef |
P980023_S018 |
Approval for addition of the steroid collar to the distal end of the lead. The device, as modified, will be marketed under the trade name kentrox sl steroid and kentrox rv steroid and is indicated fo |
242 Bytes |
2020-03-03 |
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10 |
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0 |
-
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| DevicePMAs@therightstef |
P980016_S023 |
Approval for medtronic model 7274 marquis dr dual chamber implantable cardioverter defibrillator system with model 9966 (marquis dr) application software, model 9990 desktop software, model 9322 patie |
591 Bytes |
2020-03-03 |
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10 |
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0 |
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| DevicePMAs@therightstef |
P980016_S454 |
Approval for software changes to the mycarelink patient monitor m2.5 model 24950 with model 24955 rf head which supports the devices and medtronics reveal insertable cardiac monitors models 9529, 9528 |
349 Bytes |
2020-03-03 |
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10 |
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0 |
-
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