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source DB |
source ID
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text
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# proj.
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# Ann.
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updated_at |
| DevicePMAs@therightstef |
P010015_S016 |
Approval for modifications to the device labeling to describe the care-hf clinical study. medtronic also requests a reformatting of the indications statement and the addition of a clinical outcomes se |
904 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P960040_S053 |
Approval for the vitality he model t180 implantable cardioverter defibrillator (icd) system and the consult programmer software application model 2896 version 1.0. The device is indicated as follows: |
373 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P960040_S025 |
Approval for vitality automatic implantable cardioverter defibrillator (aicd) systems (vitality dr model 1871, vitality vr model 1870 and vitality + dr model 1872), and model 2857 software, version 1. |
791 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P090013_S281 |
Approval for an update to the indications for use to include pacing at the bundle of His. The device, as modified, will be marketed under the trade name SelectSecure MRI SureScan Lead Model 3830 and i |
459 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P090013_S124 |
Approval for software changes to the mycarelink patient monitor m2.5 model 24950 with model 24955 rf head which supports the devices and medtronics reveal insertable cardiac monitors models 9529, 9528 |
349 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P090013_S200 |
Approval of the evera mri xt/s dr and vr implantable cardioverterdefibrillator devices and programmer application software model sw033 as well as extension of mr conditional labeling and use for sprin |
825 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P010012_S165 |
Approval for the teligen implantable cardioverter defibrillator models e102 and e110, the cognis cardiac resynchronization therapy defibrillator (crt-d) models n118 and n119, application software mode |
1006 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P960040_S155 |
Approval for the teligen implantable cardioverter defibrillator models e102 and e110, the cognis cardiac resynchronization therapy defibrillator (crt-d) models n118 and n119, application software mode |
1006 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P010012_S255 |
Approval for incepta, energen. punctua and teligen icd models and the incepta, energen. punctua and cognis crt-d models and prm software application model 2868 and pulse generator software. the device |
854 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P960040_S036 |
Approval for changes to the indications for use and clinical study section labeling. The devices are indicated for: for icds (ventak prx, mini, vitality, ventak av and prizm): guidant icds are inten |
1.24 KB |
2020-03-03 |
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9 |
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32 |
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