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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 |
P950022_S014 |
Approval for new defibrillation lead systems and accessories. The devices, as modified, will be marketed under the trade name riat series 1500 (models 1570, 1571, 1580 and 1581) defibrillation lead s |
493 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P090029_S000 |
Approval for the prestige lp cervical disc. this device is indicated in skeletally mature patients for reconstruction of the disc at one level from c3-c7 following single-level discectomy for intracta |
953 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P010030_S004 |
Approval for minor software, hardware, and labeling changes. The device, as modified, will be marketed under the trade name lifevest (wcd 3000) wearable defibrillator and is indicated for adult patie |
312 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P880006_S029 |
Approval is for the Model 3304 Programmer Software for use with the Model 3500 and Model 3510 Programmers. The device is indicated for the programming and interrogation of implanted St. Jude pacemake |
203 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P930016_S027 |
Approval for the upgrade star software version 5.21, star software version 5.22 and the wavescan wavefront system software version 3.671. The devices, as modified, will be marketed under the trade na |
1 KB |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P030031_S025 |
Approval for the following device modifications: 1) reduced recommended saline flow rate (reduce by ~50%); 2) increase in number of irrigation holes (from 6 to 56); 3) decrease in size of irrigation h |
1.57 KB |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P010050_S012 |
Approval for introduction of a new instrument model, the immulite 2000 xpi analyzer, as a new family member of the currently approved immulite 2000 analyzer, to be used with the currently approved imm |
501 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P090003_S000 |
Approval for the express ld iliac premounted stent system. The device is indicated for the treatment of atherosclerotic lesions found in iliac arteries up to 100 mm in length, with a reference diamet |
220 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P030039_S000 |
Approval for reference rights to p010022. The device is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage. |
177 Bytes |
2020-03-03 |
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13 |
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0 |
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| DevicePMAs@therightstef |
P950042_S003 |
Approval for the onco-life endoscopic light source and video camera (onco-life). This device is indicated for use with fluorescence imaging during bronchoscopy as an adjunct to white light imaging, t |
373 Bytes |
2020-03-03 |
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13 |
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0 |
-
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