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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 |
P970008_S001 |
Approval for a change in trade name. The device will be marketed under the trade anme Urologix Targis(TM) system and is indicated to relieve symptoms associated with benign prostatic hyperplasia (BPH |
257 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P950020_S007 |
Approval for design changes in the cutting balloon, both the over-the-wire (otw) and monorail (mr) configurations, and for manufacturing changes for the mr configuration. Additionally, approval to ad |
1.02 KB |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P170018_S000 |
Approval for the LIFEPAK CR2 Defibrillator. The device is indicated for use on patients 1 year of age and older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathin |
930 Bytes |
2020-03-03 |
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13 |
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2 |
-
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| DevicePMAs@therightstef |
P880081_S032 |
Approval for a change in haptic material, addition of the optiedge and of a modified prolate anterior optic surface to the si20nb lens and labeling claims for reduced postoperative spherical aberratio |
650 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P960057_S000 |
Approval for ADCON(R)-L Adhesion Barrier Gel. This device is indicated for use during single level, posterior lumbar laminectomy or laminotomy procedures where nerve roots are exposed to inhibit post |
228 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P970031_S011 |
Approval for the freestyle aortic root bioprosthesis, model 995, size 29 mm; implantation techniques, subcoronary, full-root, and root inclusion. The supplement requested approval of this size as an |
426 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P050052_S000 |
Approval for radiesse. This device is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. |
169 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P960040_S031 |
Approval for the vitality ds vr model t135, vitality ds model t125, and vitality el model t127 implantable cardioverter defibrillator systems and the programmer software application model 2844 version |
1000 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P990066_S019 |
Approval for changes in two software modifications that have been made to the acquisition workstation (aws) and for an additional supplier for the conditioner (chiller for the image receptor). The de |
656 Bytes |
2020-03-03 |
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13 |
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0 |
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| DevicePMAs@therightstef |
P010031_S232 |
Approval for a modification to the indications for use as follows. for the concerto crt-d model c154dwk, consulta crt-d model d224trk, concerto ii crt-d model d274trk, protecta crt-d model d334trg, pr |
1.72 KB |
2020-03-03 |
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11 |
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0 |
-
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