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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 |
N50510_S136 |
Approval for the addition of the antibiotic tetracycline at concentrations of 0.5, 1 and 2 micrograms/.ml to the vitek(r) 2 s. pneumoniae susceptibility test system. The device, ad modified, will be |
456 Bytes |
2020-03-03 |
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13 |
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0 |
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| DevicePMAs@therightstef |
P990046_S005 |
Approval to combine the ats open pivot bileaflet heart valve (approved on october 13, 2000 under p990046) with the meadox hemashield woven double velour vascular graft (approved on may 11, 1993 under |
547 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P980035_S022 |
Approval for the medtronic/vitatron carelink programmer model 2090, model 2067 carelink programmer rf head, model 2290 lead analyzer, model 2292 analyzer cable, model 2091 carelink programmer modem, m |
1.56 KB |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P970052_S000 |
Approval for the FACT(TM), ARC(TM), LYNX(TM) and Guardian(TM) Balloon Coronary Dilatation Catheters. These devices are indicated for balloon dilatation of the stenotic portion of a coronary artery or |
519 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P980016_S000 |
Approval for the Medtronic(R) Model 7271 GEM(TM) DR Dual Chamber Implantable Cardioverter Defibrillator System with Mdoel 9960 (GEM(TM) DR) Application Software, Medtronic(R) Model 6940 CapSureFix(R) |
737 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P010031_S015 |
Approval for the insync sentry model 7297 icd and model 9998 application software version 1.2. The device is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automa |
554 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P990085_S000 |
The vistakon spherical (lenefilcon a) contact lens is indicated for daily and extended wear for the correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased e |
1.34 KB |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P980016_S492 |
Approval for the mycarelink smart monitor used with the device. The device, as modified, will be marketed under the trade name mycarelink smart monitor andthe mycarelink heart application and is indi |
639 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P130021_S033 |
Approval for the Medtronic CoreValve System, CoreValve Evolut R System, and CoreValve Evolut PRO System. The devices are indicated for relief of aortic stenosis in patients with symptomatic heart dis |
571 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P890003_S050 |
Approval for new pacing lead models. The devices, as modified, will be marketed under the trade names: Medtronic Models 5038-58, 5038-65, 5038-52, 5038S-58, and 5038L-65 CapSure VDd-2 and Vitatron M |
411 Bytes |
2020-03-03 |
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11 |
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0 |
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