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# proj.
# Ann.
updated_at
DevicePMAs@therightstef
P110021_S026
Approval for removal of access approach from device labeling. the device is indicated for patients w
694 Bytes
2020-03-03
13
0
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DevicePMAs@therightstef
P060038_S002
Approval for manufacturing process improvements to the aortic pericardial heart valve model 12. The
321 Bytes
2020-03-03
13
0
-
DevicePMAs@therightstef
P150048_S000
Approval of the Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve.
373 Bytes
2020-03-03
13
0
-
DevicePMAs@therightstef
P060025_S010
Approval for changes to the rinsing and fixations solutions used inthe manufacture of the device. th
309 Bytes
2020-03-03
13
0
-
DevicePMAs@therightstef
P060038_S017
Approval for manufacturing process changes to the mitroflow aortic pericardial heart valve, model lx
499 Bytes
2020-03-03
13
0
-
DevicePMAs@therightstef
P010068_S009
Approval for adding remote magnetic navigation technology to the previously approved catheter. The
823 Bytes
2020-03-03
13
0
-
DevicePMAs@therightstef
P010068_S002
Approval for modifications mad to the navistar ds 8mm tip deflectable diagnostic/ablation catheter a
580 Bytes
2020-03-03
13
0
-
DevicePMAs@therightstef
P030031_S025
Approval for the following device modifications: 1) reduced recommended saline flow rate (reduce by
1.57 KB
2020-03-03
13
0
-
DevicePMAs@therightstef
P020025_S036
Approval for blazer prime xp catheter design modifications, material packaging, labeling changes, an
691 Bytes
2020-03-03
13
0
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DevicePMAs@therightstef
P040042_S000
Approval for the therapy dual 8 cardiac ablation system. The device is indicated for the treatment
126 Bytes
2020-03-03
13
0
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