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> DevicePMAs@therightstef
age_PMA_annotations
Documents
(2,258)
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DevicePMAs@therightstef
P970004_S009
Approval for the model 3095a lead extension kit for use with the medtronic(r) interstim(r) system for urinary control, which is indicated for the treatment of urinary urge incontinence, urinary retent
330 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P150048_S000
Approval of the Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve. The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for the replacement of nat
373 Bytes
2020-03-03
13
0
-
DevicePMAs@therightstef
P040051_S000
Approval for the stelkast surpass acetabular system. The device is indicated for cementless use in primary total hip arthroplasty in skeletally mature individuals with non-inflammatory degenerative j
307 Bytes
2020-03-03
11
0
-
DevicePMAs@therightstef
P960043_S044
Approval to: replace the brained suture with a monofilament polypropylene suture; combine the instructions for use of the perclose a-t monofilament 6 fr. suture mediated closure (smc) system and the c
840 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P890003_S073
Approval for the model 2490e carelink monitor and model 2491 ddma software to allow their use with the maximo dr/vr, models 7278 & 7232 and insync ii marquis, model 7289 devices. The carelink system
374 Bytes
2020-03-03
11
0
-
DevicePMAs@therightstef
P930038_S029
Approval for the self-tightening slipknot (sts) modification to the angio-seal vascular closure device. The device, as modified, will be marketed under the trade name angio-seal vascular closure devi
575 Bytes
2020-03-03
11
0
-
DevicePMAs@therightstef
P110022_S000
Approval for the elecsys anti-hbc igm immunoassay and elecsys precicontrol anti-hbc igm for use on the cobas e 601 immunoassay analyzer. this device is indicated for: the elecsys anti-hbc igm immunoas
1.06 KB
2020-03-03
11
0
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DevicePMAs@therightstef
P100021_S063
Approval for the expansion of the indications for use of the Endurant II/Endurant IIs Stent Graft System to include the treatment of infrarenal abdominal aortic aneurysms having neck lengths >= 4 mm a
1.6 KB
2020-03-03
11
0
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DevicePMAs@therightstef
P030009_S001
Approval for adding the mx2 catheter to this product line. The device, as modified, will be marketed under the trade name driver mx2 coronary stent system and is indicated for improving coronary lumi
497 Bytes
2020-03-03
11
0
-
DevicePMAs@therightstef
P130004_S000
Approval for the resure sealant. this device is indicated for intraoperative management of clear corneal incisions (up to 3.5mm) with a demonstrated wound leak for which a temporary dry surface can be
353 Bytes
2020-03-03
13
0
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