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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 |
P860019_S150 |
Approval for the SCIMED NC MAXXUM(TM) PTCA Catheter (20mm balloon length with balloon diameters of 2.0mm, 2.5-4.0mm in 1/4mm increments and 4.5mm, -5.0mm in 1/2mm increments; and 9mm and 15mm lengths |
638 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P090016_S000 |
Approval for belotero balance. This 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. |
187 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P050016_S002 |
Approval for the addition of intermediate sizes for both the femoral head (42mm, 46mm, 50mm, and 54mm) and the corresponding acetabular cup components within the product line for the cormet hip resurf |
660 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P830039_S011 |
Approval for the omnicarbon cardiac valve prosthesis in the additional size of 21 mm of the model 3313 (aortic) and size 25 mm of the model 3523 (mitral). The supplement requested approval of these s |
476 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 |
P070009_S003 |
Approval for a line extension to the realize adjustable gastric bandthe device, as modified, will be marketed under the trade name realize adjustable gastricband curved (model bd3xv) and is indicated |
599 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P990081_S002 |
Approval of labeling changes for the pathway her-2/neu (clone cd11) in the "intended use" section, addition of an "optional equipment not provided" section and changes to the "principles and procedure |
1.67 KB |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P940016_S000 |
Approval for the H. E. L. P. System. The device is a low density lipoprotein cholesterol (LDL-C) apheresis system, indicated for use in perofrming LDL-C apheresis to acutely remove LDL-C from the pla |
289 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P110019_S025 |
Approval for a newly designed delivery catheter. the device, as modified, will be marketed under the trade name xience xpedition; xience xpedition small vessel (sv) and xience xpedition long lesion (l |
463 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P980006_S008 |
Approval for a multifocal design of the bausch & lomb purevision visibility tinted contact lenses and is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and |
858 Bytes |
2020-03-03 |
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11 |
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0 |
-
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