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PMA_Manual
Documents
(2,258)
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# proj.
# Ann.
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DevicePMAs@therightstef
P150009_S000
Approval of the AngelMed Guardian System. This device is indicated for use in patients who have had
870 Bytes
2020-03-03
13
0
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DevicePMAs@therightstef
P180014_S000
Approval for the XPS with Steen Solution Perfusate. This device is indicated for use in flushing an
290 Bytes
2020-03-03
13
0
-
DevicePMAs@therightstef
P160029_S000
Approval for the HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (M
1.19 KB
2020-03-03
13
0
-
DevicePMAs@therightstef
P800035_S011
Approval for design changes, a trade name change, and new manufacturing sites. This approval also a
799 Bytes
2020-03-03
13
0
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DevicePMAs@therightstef
P160050_S000
Approval for the Barricaid Anular Closure Device (ACD). The device is indicated for reducing the inc
586 Bytes
2020-03-03
13
0
-
DevicePMAs@therightstef
P170013_S000
Approval for the Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. This device is ind
363 Bytes
2020-03-03
13
0
-
DevicePMAs@therightstef
P160053_S000
Approval for the MagtraceTM and Sentimag Magnetic Localization System. The MagtraceTM and Sentimag
384 Bytes
2020-03-03
13
0
-
DevicePMAs@therightstef
P950037_S084
Approval for two new families of temporary external pacemaker pulse generators. New features includ
731 Bytes
2020-03-03
13
0
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DevicePMAs@therightstef
P130025_S000
Approval for the koning breast ct (model cbct 1000). this device is indicated as follows: koning bre
333 Bytes
2020-03-03
13
0
-
DevicePMAs@therightstef
P950020_S010
Approval for design, manufacturing, and labeling changes in the cutting balloon, both over-the-wire
429 Bytes
2020-03-03
13
0
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