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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 |
P900023_S047 |
Approval for the ipulse circulatory support system, a unit that will support patients in need of full circulatory support using the bvs 5000 blood pump or the ab5000 ventricle, or partial ventricular |
469 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P000055_S000 |
Approval for the ubis 5000. The ubis 5000 is a quantitative ultrasound (aus) bone sonometer and is indicated for the measurement of broadband ultrasound attenuation (bua) of the calcaneus, as an aid |
343 Bytes |
2020-03-03 |
|
13 |
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0 |
-
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| DevicePMAs@therightstef |
P100023_S053 |
Approval for removal of the ball from the tip of the corewire which islocated between the inner and outer lumen of the stent delivery system. the device, as modified, will be marketed under the trade |
757 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P040044_S056 |
Approval to expand the indications for use to include closure of venous access sites in addition to the currently approved use for closure of arterial access sites. the device, as modified, will be ma |
520 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P960043_S035 |
Approval for a modification of the closer s suture-mediated closure (smc) device to allow for a pre-tied knot upon device use. The device, as modified, will be marketed under the trade name closer ii |
693 Bytes |
2020-03-03 |
|
13 |
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0 |
-
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| DevicePMAs@therightstef |
P150003_S000 |
Approval for the synergy everolimus-eluting platinum chromium coronary stent system. this device is indicated for improving luminal diameter in patients with symptomatic heart disease, stableangina, u |
388 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P020050_S019 |
Approval to expand the approval of the topolyzer vario to include its use as a diagnostic device supporting the wavelight excimer lasers in performing t-cat lasik. the device, as modified, will be mar |
1.02 KB |
2020-03-03 |
|
13 |
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0 |
-
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| DevicePMAs@therightstef |
P000021_S000 |
Approval for the dimension(r) rxl psa flex(r) reagent cartridge. The device is indicated for the following: the psa method for the dimension(r) clinical chemistry system with the heterogeneous immun |
596 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P860019_S162 |
Approval for the boston scientific scimed maverick(tm) over-the-wire (otw) percutaneous transluminal coronary angioplasty (ptca) catheter (9, 12, 15, 20, 25 and 30 mm lengths with balloon diameters of |
641 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P970034_S000 |
Indicated for the visual correction of aphakia in persons 60 years of age or older, who are undergoing extracapsular cataract extraction and primary lens implantation. The intraocular lens is intende |
439 Bytes |
2020-03-03 |
|
11 |
|
0 |
-
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