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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 |
P100009_S028 |
Approval for the MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System for expanding the indication to include secondary mitral regurgitation. The devices, when used with maxima |
802 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P860004_S070 |
Approval for the model 8832 personal therapy manager (ptm), an accessory to the synchromed ii implantable infusion system, indicated for the patient to activate delivery of physician programmed supple |
342 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P010059_S003 |
Approval for the addition of capsular tension rings (ctrs) models1g, 2s, 6d, 6e, and 10c and change in packaging to incorporate the morcher injector preloaded with ctr models 14, 14a, and 14c. the dev |
803 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P890003_S000 |
Approval for the Synergyst II Models 7070 and 7071 Pulse Generators and the Model 9710 Programmer with the Model 9739A MemoryMod. This device is indicated for cardiac pacing. |
175 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P960040_S039 |
Approval for the vitality 2 icd system (models t165, t167, t175, t177), model 2857 application software (version 2.2), and quick profiles disk (model 2828 version 1.0). The device is indicated for us |
691 Bytes |
2020-03-03 |
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10 |
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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 |
P010029_S001 |
Approval for 1) changing the storage conditions specified in the product labeling from, ?store in a cold dark place [2 ? 8 degrees c (36-46 degrees f)]. Protect from light. Do not freeze?. 2) chang |
597 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P990037_S000 |
Approval for the vascular solutions duett(tm) sealing device. This device is indicated for sealing femoral arterial puncture sites and reducing time to hemostasis and ambulation in patients who have |
340 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P160042_S000 |
Approval for the Revanesse Ultra. The device is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults |
225 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P010054_S003 |
Approval for a change in the standardization process for the assay. the device, as modified, will be marketed under the trade name elecsys anti-hbs immunoassay and elecsys precicontrol anti-hbs and is |
1.39 KB |
2020-03-03 |
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11 |
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0 |
-
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