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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 |
P080027_S000 |
Approval for the oraquick rapid hcv antibody test. The device is indicated for the qualitative detection of antibodies to hepatitis c virus (anti-hcv) in venipuncture whole blood specimens (edta, sod |
624 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P790017_S066 |
Approval for the addition of three balloon sizes to the USCI(R) Apollo(TM) Rely(R) Over-the-Wire Balloon Dilatation Catheter with Hydro/Pel(R) Coating and Miniquet Device catheter line. The device is |
354 Bytes |
2020-03-03 |
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11 |
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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 |
P980041_S003 |
Approval for expanding the use of access afp reagents on the unicel dxl 800 access immunoassay system. The device, as modified, will be marketed under the trade name access afp immunoassay system and |
742 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P830039_S011 |
Approval for the omnicarbon cardiac valve prosthesis in the additional size of 21 mm of the model 3313 (aortic) and size 25 mm of the model 3523 (mitral). The supplement requested approval of these s |
476 Bytes |
2020-03-03 |
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13 |
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0 |
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| DevicePMAs@therightstef |
P030009_S039 |
Approval for the integrity coronary stent system. the device is indicated for improvingcoronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo or restenot |
321 Bytes |
2020-03-03 |
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11 |
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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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9 |
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| DevicePMAs@therightstef |
P910065_S004 |
Approval for design changes to include reduction of the incubation time from 40 to 10 minutes, change in the conjugate diluent, decrease in alp activity and change in packaging size from 200 tests to |
931 Bytes |
2020-03-03 |
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13 |
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4 |
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| DevicePMAs@therightstef |
P010052_S008 |
Approval for introduction of a new instrument model, the immulite 2000 xpi analyzer, as a new family member of the currently approved immulite 2000 analyzer, to be used with the currently approved imm |
492 Bytes |
2020-03-03 |
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11 |
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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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