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> DevicePMAs@therightstef
blah6_medical_device
Documents
(2,258)
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DevicePMAs@therightstef
P110032_S000
Approval for the aorfix aaa flexible stent graft system. this device is indicated for the treatment of patients with abdominal aortic and aorto-iliac aneurysms having vascular morphology suitable for
666 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P080011_S035
Approval for a change in trade name for the biofinity energys aspheric lens and expanded powers for the biofinity xr toric and biofinity xr multifocal lenses. the devices, as modified, will be markete
1.4 KB
2020-03-03
11
0
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DevicePMAs@therightstef
P950020_S004
Approval for a rapid exchange version of the cutting balloon. The device, as modified, will be marketed under the trade name cutting balloon monorail and is indicated for dilatation of stenosis in co
792 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P000023_S000
Approval for the tmj fossa-eminence/condylar prosthesis system. The device is indicated for reconstruction of the temporomandibular joint. Patients should be considered if they have one or more of t
705 Bytes
2020-03-03
13
0
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DevicePMAs@therightstef
P810046_S230
Approval to modify the protective balloon sheath. The device, as modified, will be marketed under the trade name voyager nc coronary dilatation catheter and is indicated for: 1) balloon dilation of t
526 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P010012_S160
Approval for the acuity spiral lead model 4591, 4592, and 4593. The device is indicated for chronic, left-ventricular pacing and sensing via the coronary veins when used in conjunction with a compati
220 Bytes
2020-03-03
10
0
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DevicePMAs@therightstef
P930016_S057
Approval for the STAR S4 IR Excimer Laser System and iDESIGN Refractive Studio. This device is indicated for wavefront-guided photorefractive keratectomy (PRK) in patients: 1) with myopia, with or w
868 Bytes
2020-03-03
13
0
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DevicePMAs@therightstef
P010018_S005
Approval for the viewpoint ck system. The device is indicated for the temporary induction of myopia (-1.00 d to -2.00 d) to improve near vision in the non-dominant eye of presbyopic hyperopes or pres
734 Bytes
2020-03-03
13
0
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DevicePMAs@therightstef
P140010_S015
Approval for the IN. PACT Admiral Paclitaxel-coated PTA Balloon Catheter. The device is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo, restenot
348 Bytes
2020-03-03
13
0
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DevicePMAs@therightstef
P040021_S004
Approval for the epic valve in aortic sizes 21, 23, 25, 27 and 29 mm, and in mitral sizes 27, 29, 31 and 33 mm, and the sjm epic supra valve in aortic valve sizes 19, 21, 23, 25 and 27 mm. The device
441 Bytes
2020-03-03
11
0
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