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> DevicePMAs@therightstef
age_PMA_annotations
Documents
(2,258)
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# proj.
# Ann.
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DevicePMAs@therightstef
P010015_S006
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
11
0
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DevicePMAs@therightstef
P980016_S046
Approval for the medtronic entrust models d153atg, d153drg, d153vrc, d154atg, d154drg, d154vrc, medtronic model 9987 application software and the medtronic model 2696 incheck patient assistant are ind
1.91 KB
2020-03-03
9
0
-
DevicePMAs@therightstef
P850079_S038
Approval for the frequency multifocal (methafilcona) soft (hydrophilic) contact lenses for extended wear (clear and tinted). The lenses are indicated for extended wear from 1 to 7 days between remova
564 Bytes
2020-03-03
11
0
-
DevicePMAs@therightstef
P000018_S028
Approval for the 60 mm beta-cath 3.5f system. The device, as modified, is indicated to deliver beta radiation to the site of successful percutaneous coronary intervention (pci) for the treatment of i
445 Bytes
2020-03-03
13
0
-
DevicePMAs@therightstef
P890064_S021
Approval for a trade name change for the hybrid capture 2 (hc2) high-riskhpv dna test and hybrid capture 2 (hc2) hpv dna test. the devices, as modified, will bemarketed under the trade name digene hyb
411 Bytes
2020-03-03
13
0
-
DevicePMAs@therightstef
P010049_S012
Approval to add a polysaccharide (chitosan) to the hemostatic pledget formulation and requested to rename the device from the quickseal surestat arterial closure system to the surestat arterial closur
893 Bytes
2020-03-03
11
0
-
DevicePMAs@therightstef
P060008_S053
Approval for: 1) a change of the supplier of toluene; and 2) a change to the incoming toluene specifications. The device is indicated for improving luminal diameter for the treatment of de novo lesio
286 Bytes
2020-03-03
11
0
-
DevicePMAs@therightstef
P040004_S004
Approval for adding advia centaur xp instrument to the intended use of theapproved device advia centaur hbc total assay. the device, as modified, will be marketed under the trade name advia centaur hb
1013 Bytes
2020-03-03
11
0
-
DevicePMAs@therightstef
P060027_S000
Approval for the ovatio crt-d system. the ovatio crt-d is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. the d
618 Bytes
2020-03-03
11
0
-
DevicePMAs@therightstef
P980016_S062
Approval for the medtronic virtuoso dr/vr models d154a wg/d154vwc implantable cardioverter defibrillators and the concerto - virtuoso v 1.0 software application model sw002. The medtronic virtuoso dr
1.81 KB
2020-03-03
11
0
-
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