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> DevicePMAs@therightstef
PMA_age_indications
Documents
(2,236)
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DevicePMAs@therightstef
P030025_S017
Approval to change the in-process coating weight acceptance criteria. The device, as modified, will be marketed under the trade name taxus express2 paclitaxel-eluting coronary stent system and is ind
351 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P100023_S000
Approval for the ion paclitaxel-eluting coronary stent system. This device is indicated for improving luminal diameter for the treatment of de nove lesions in native coronary arteries >=2.25 mm to <=
247 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P060008_S000
Approval for the taxus libert paclitaxel-eluting coronary stent system. The device is indicated for improving luminal diameter for the treatment of de novo lesions <= 28 mm in length in native corona
247 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P070015_S128
Approval for the xience v and xience nano everolimus eluting coronary stent system, xience prime and xience prime ll everolimus eluting coronary stent system, xience xpedition, xience xpedition sv and
1.89 KB
2020-03-03
11
0
-
DevicePMAs@therightstef
P030025_S021
Approval for stent diameters which expand the product matrix to include 2.25 mm and 4.0mm taxus express2 paclitaxel-eluting coronary stent systems. the device, asmodified, will be marketed under the t
560 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P160043_S000
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
376 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P110013_S000
Approval for the resolute microtrac zotarolimus-eluting coronary stent system and resolute integrity zotarolimus-eluting coronary stent systems. These devices are indicated for improving coronary lum
431 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P110013_S088
Approval for the Resolute Integrity Zotarolimus-Eluting Coronary Stent System. The device is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, wi
499 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P110019_S066
Approval for the expansion of the indications for use of the xience v and xience nano everolimus eluting coronary stent system xience prime and xience prime ll everolimus eluting coronary stent system
1.31 KB
2020-03-03
11
0
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DevicePMAs@therightstef
P020026_S000
Approval for the cypher sirolimus-eluting coronary stent on the raptor over-the-wire delivery system or raptorrail rapid exchange delivery system. The device is indicated for improving coronary lumin
481 Bytes
2020-03-03
11
0
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