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age_PMA_annotations
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DevicePMAs@therightstef
N16374_S036
Approval for the PRONOVA Non-absorbable Suture manufactured from poly (vinylidene fluoride) and poly (vinylidene fluoride-co-hexafluoropropylene). The device, as modified, will be marketed under the
370 Bytes
2020-03-03
13
0
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DevicePMAs@therightstef
P960057_S004
Approval for a patient brochure. The device is indicated for use during single level, posterior lumbar laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis.
199 Bytes
2020-03-03
13
0
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DevicePMAs@therightstef
P970004_S009
Approval for the model 3095a lead extension kit for use with the medtronic(r) interstim(r) system for urinary control, which is indicated for the treatment of urinary urge incontinence, urinary retent
330 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P180046_S000
Approval for the Axonics Sacral Neuromodulation System. The device is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and
346 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P890055_S032
Approval for a new adhesive to secure the antenna and modification to the piezo actuator release specification. the device, as modified, will be marketed under the trade name medstream programmable in
364 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P990018_S000
Approval for the menicon z(tm) (tisilfocon a) rigid gas permeable lens. Menicon z(tm) (tisilfocon a) spherical or aspheric lenses and non-prism ballast toric lenses are indicated for extended wear (f
498 Bytes
2020-03-03
13
0
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DevicePMAs@therightstef
P950005_S010
Approval for expanding the indications for use. The device, as modified, will be marketed under the trade name celsius diagnostic/ablation deflectable tip catheter and is indicated as follows: the b
568 Bytes
2020-03-03
13
0
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DevicePMAs@therightstef
P140003_S000
Approval for the impella. this device is indicated for: the impella 2.5 system is a temporary (<= 6 hours) ventricular support device indicated for use during high risk percutaneous coronary intervent
739 Bytes
2020-03-03
13
0
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DevicePMAs@therightstef
P130025_S000
Approval for the koning breast ct (model cbct 1000). this device is indicated as follows: koning breast ct (cbct1000) is a cone beam computed tomography system intended to provide three dimensional im
333 Bytes
2020-03-03
13
0
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DevicePMAs@therightstef
P950020_S072
Approval for updates to the atherotomes, adhesive, balloon catheter platform, device packaging and the sterilization process. The device, as modified, will be marketed under the trade name WOLVERINE
883 Bytes
2020-03-03
13
0
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