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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 |
P160029_S000 |
Approval for the HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A). The HeartStart OnSite Defibrillator (M5066A) is indicated for use on potential victim |
1.19 KB |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P010043_S000 |
Approval for the lea's shield barrier contraceptive. The device is indicated for use by women of childbearing age who desire to prevent or postpone pregnancy. |
159 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| 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 |
P960013_S013 |
Approval for addition of a fluoroscopic marker in the helix tip, and is indicated for permanent sensing and pacing in either the atrium or the ventricle, in combination with a compatible pulse generat |
203 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P950037_S019 |
Approval for modifications to the hardware and software, including: 1) the addition of a low-power, radiofrequency (rf) transmitter to the implantable pulse generator (ipg); 2) modification of the i |
1.95 KB |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P070026_S000 |
Approval for the ceramax ceramic total hip system. This device is indicated for noncemented use in skeletally mature individuals undergoing primary total hip replacement surgery for rehabilitation of |
382 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P010030_S056 |
Approval for the lifevest wearable cardioverter defibrillator, models 3000, 3100, and 4000. the lifevest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac a |
589 Bytes |
2020-03-03 |
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13 |
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4 |
-
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| DevicePMAs@therightstef |
P170018_S000 |
Approval for the LIFEPAK CR2 Defibrillator. The device is indicated for use on patients 1 year of age and older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathin |
930 Bytes |
2020-03-03 |
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13 |
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2 |
-
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| DevicePMAs@therightstef |
P160033_S000 |
Approval for the Powerheart AED G3, Powerheart AED G3 Plus, and the Powerheart AED G5.The Powerheart AED G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest |
2.03 KB |
2020-03-03 |
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13 |
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9 |
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| DevicePMAs@therightstef |
P020050_S006 |
Approval for increased pulse frequency from 400 to 500 hz, a new laser head, a new housing with greater integration of accessories, modified laser pulse temporal parameters, new eyetracker, new scanne |
1.94 KB |
2020-03-03 |
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13 |
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8 |
-
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