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source DB |
source ID
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text
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size
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updated at |
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# proj.
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# Ann.
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updated_at |
| DevicePMAs@therightstef |
P820018_S074 |
Approval for modifications to the epic ii/epic ii+ and epic ii hf devices. The modifications include adding a vibratory patient notifier; modifying the electrogram morphology algorithm; modifying the |
1.6 KB |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P020025_S036 |
Approval for blazer prime xp catheter design modifications, material packaging, labeling changes, and addition of accessories: intellatip mifi cable, filter module, and reference cable for the intella |
691 Bytes |
2020-03-03 |
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13 |
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0 |
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| DevicePMAs@therightstef |
P160047_S000 |
Approval for the AEGEA Vapor System (including the AEGEA Vapor Probe Procedure Kit, AEGEA Vapor Generator, and AEGEA Vapor Generator Accessory Kit). This device is indicated to ablate the endometrial |
345 Bytes |
2020-03-03 |
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13 |
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0 |
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| DevicePMAs@therightstef |
P960040_S026 |
Approval for the ventak prizm 2 vr/dr models 1860/1861, ventak prizm vr/dr models 1850/1851/1855/1856, ventak prizm vr/dr he models 1852/1853, ventak mini iv models 1790/1793/1796 and ventak mini iii |
598 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P110037_S001 |
Approval for a change to the test definition file (tdf). The device, as modified, will be marketed under the trade name cobas ampliprep/cobas taqman cmv test and is indicated for: cobas ampliprep/co |
1.1 KB |
2020-03-03 |
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13 |
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0 |
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| DevicePMAs@therightstef |
P850089_S045 |
Approval to distribute the medtronic(r) capsure(r) z novus models 5054 and 5554 pacing leads under a new trade name. The devices will be marketed under the trade name vitatron impluse ii models ihp 0 |
382 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P990055_S012 |
Approval for the addition of the advia centaur xp instrument (with version 5.0software) to the instrument(s) using the advia centaur cpsa assay. the device, as modified, will be marketed under the tra |
609 Bytes |
2020-03-03 |
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13 |
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0 |
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| DevicePMAs@therightstef |
P950037_S042 |
Approval for modifications to the selox sr pacing lead family to change the steroid dosage, maximum lead body diameter, and ring electrode base material, as well as other minor changes. The device, a |
365 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P030031_S025 |
Approval for the following device modifications: 1) reduced recommended saline flow rate (reduce by ~50%); 2) increase in number of irrigation holes (from 6 to 56); 3) decrease in size of irrigation h |
1.57 KB |
2020-03-03 |
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13 |
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0 |
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| DevicePMAs@therightstef |
P140015_S020 |
Approval for the use of the t: slim X2 Insulin Pump with the Dexcom G5 Mobile CGM and for modifying the indications for use to include pediatric patients ages 6-11 years and replace adjunctive with no |
1.68 KB |
2020-03-03 |
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13 |
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0 |
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