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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 |
P030045_S000 |
Approval for the intrastent doublestrut stent. The device is indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease of the common and/or external iliac arteries |
272 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P990055_S012 |
Approval for the addition of the advia centaur xp instrument (with version 5.0software) to the instrument(s) using the advia centaur cpsa assay. the device, as modified, will be marketed under the tra |
609 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P100034_S000 |
Approval for the novottf-100a system. The device is indicated for treatment of adult patients (22 years of age or older) with histologically- confirmed glioblastoma multiforme, following histological |
496 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P080004_S013 |
Approval for the model 731 intraocular lens (iol), which adds acontrolled positive spherical aberration to the optic. the device, as modified, will be marketed under the trade name isert gemetric and |
368 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P030011_S020 |
Approval for the freedom driver system. the device, as modified, will be marketed under the trade name syncardia temporary total artificial heart with the freedom driver system and is indicated for us |
331 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P990025_S011 |
Approval for a minor labeling revision for the 4 mm qwikstar diagnostic/ablation catheter to include the noga xp navigation system as an optional mapping system for the qwikstar catheter. The device, |
711 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P060028_S000 |
Approval for thememoryshape breast implants. this device is indicated for females for the following uses(procedures):1) breast augmentation for women at least 22 years old. breast augmentation include |
716 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
N50510_S099 |
Approval for the addition of the antibiotic benzylpenicillin at concentrations of 0.125, 0.25, 1, 2, 8 and 64ug/ml to the Vitek(R) 2 Gram Positive Susceptibility Test System. The device is indicated |
373 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P960058_S032 |
Approval for an optional accessory item that can be used with the platinum headpiece and auria headpiece. This item, named headpiece spacer, is a passive piece of elastomer intended to be placed betw |
524 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P900043_S031 |
Approval for the hepacoat on bx sonic balloon-expandable stent otw delivery system. The device, as modified, is indicated for improving coronary luminal diameter in the following: 1) for treatment o |
883 Bytes |
2020-03-03 |
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11 |
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0 |
-
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