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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_S131 |
Approval for a modification of the SCIMED Ranger(TM) PTCA Catheter, with the primary difference being use of a new balloon material. The device, as modified, will be marketed under the trade name SCI |
516 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P070026_S003 |
Approval for the addition of the trio-lock bps (bone preserving hip stem) and 28 mm ceramic femoral heads with a 12/14 taper and +1.5 mm, +5 mm, and 8.5 mm offset as compatible modular components to t |
716 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P900061_S044 |
Approval for the general use indication for implantable cardioverter defibrillator models micro jewel 7221, micro jewel ii 7223, gem dr 7271, gem ii dr 7273 and gem ii vr 7229 and are indicated to pro |
339 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P000052_S004 |
Approval for the galileo iii intravascular radiotherapy system. The device, as modified, will be marketed under the trade name galileo iii intravascular radiotherapy system and is indicated as follow |
509 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P160039_S000 |
Approval for the remed System. This device is an implantable phrenic nerve stimulator indicated for the treatment of moderate to severe central sleep apnea (CSA) in adult patients. |
181 Bytes |
2020-03-03 |
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13 |
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0 |
-
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| DevicePMAs@therightstef |
P790017_S066 |
Approval for the addition of three balloon sizes to the USCI(R) Apollo(TM) Rely(R) Over-the-Wire Balloon Dilatation Catheter with Hydro/Pel(R) Coating and Miniquet Device catheter line. The device is |
354 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P960016_S005 |
Approval for eight new 4 mm tip electrode catheters with thermistor only temperature sensing. The catheters, as modified, will be marketed under the trade name livewire tc(tm) cardiac ablation system |
509 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P990004_S022 |
Approval for a change in the wording of the indication for use statement. prior ifu: surgiflo hemostatic matrix, mixed with sterile saline or thrombin solution, is indicated for surgical procedures (e |
649 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P840024_S070 |
Approval to implement a design change to the two-pin socket on the headset microphone. The transmitting coil is connected to the microphone via a cable which is plugged into this two-pinc socket. Th |
849 Bytes |
2020-03-03 |
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11 |
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7 |
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| DevicePMAs@therightstef |
P010054_S004 |
Approval for a modification to the standardization process for the elecsys anti-hbs immunoassay and elecsys precicontrol anti-hbs assay for use on the elecsys 2010 analyzer. The device, as modified, |
374 Bytes |
2020-03-03 |
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11 |
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0 |
-
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