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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 |
P990056_S000 |
Approval for the elecsys(r) total psa immunoassay and elecsys(r) total psa calset. The device, a quantitative in vitro diagnostic test for total prostate-specific antigen (tpsa) in human serum and pl |
686 Bytes |
2020-03-03 |
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13 |
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0 |
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| DevicePMAs@therightstef |
P010029_S000 |
Approval for nuflexxa (1% sodium hyaluronate). The device is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservative n |
273 Bytes |
2020-03-03 |
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13 |
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0 |
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| DevicePMAs@therightstef |
P000009_S043 |
Approval for the ics 3000 programmer application software version psw 1004.u, and the estella dr; estella dr-t; estella sr; estella sr-t; ecuro dr; ecuro dr-t; ecuro sr; ecuro sr-t; effecta d; effecta |
363 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
N50510_S136 |
Approval for the addition of the antibiotic tetracycline at concentrations of 0.5, 1 and 2 micrograms/.ml to the vitek(r) 2 s. pneumoniae susceptibility test system. The device, ad modified, will be |
456 Bytes |
2020-03-03 |
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13 |
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0 |
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| DevicePMAs@therightstef |
P010019_S003 |
Approval for 1) a modification to the lotrafilcon a material to market lotrafilcon b contact lenses with an indication for up to 6 nights of extended wear; 2) incorporation of a light blue handling ti |
1.95 KB |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P160043_S001 |
Approval for the Resolute Onyx Zotarolimus-Eluting Coronary Stent System. This device is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, with s |
356 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P930012_S010 |
Approval for 1) a change in trade names for the Champion(TM) HP PTCA Catheters and Champion(TM) HP PTCA Catheters with Wrap(TM) Sheathing System previously approved under PMA supplements 5, 8, and 9, |
594 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P110042_S000 |
Approval for the subcutaneous implantable defibrillator (s-icd) system. this device is indicated to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in |
402 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P080020_S020 |
Approval for Gel-One. The device is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroida |
271 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P020049_S000 |
Approval for the procol vascular bioprosthesis. The device is indicated for the creation of a bridge graft for vascular access subsequent to at least one previously failed prosthetic access graft. |
197 Bytes |
2020-03-03 |
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13 |
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0 |
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