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> DevicePMAs@therightstef
PMA_age_indications
Documents
(2,236)
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DevicePMAs@therightstef
P890003_S000
Approval for the Synergyst II Models 7070 and 7071 Pulse Generators and the Model 9710 Programmer with the Model 9739A MemoryMod. This device is indicated for cardiac pacing.
175 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P910023_S081
Approval for the convert and convert+ icd systems with the application software model 3307 version 4.9. The device, as modified, will be marketed under the trade name convert and convert+ icd systems
382 Bytes
2020-03-03
11
0
-
DevicePMAs@therightstef
P980035_S000
Approval for the Medtronic. Kappa(TM) 700/600 Series Pacemakers, which include; Medtronic. Kappa(TM) Kdr 701, 703, 706, 721, 731, 733, 601, 603, and 606; Kd 701, 703, and 706; Kvdd 701; and Ksr 701, 7
1.94 KB
2020-03-03
11
0
-
DevicePMAs@therightstef
P880086_S145
Approval for the model 3330 version6.1.1 software for the model 3650 merlin patient care system and model 3307 version 6.4.1 software for the model 3510 programmer which enables v-v timing, af suppres
538 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P910023_S138
Approval for the model 3330 version6.1.1 software for the model 3650 merlin patient care system and model 3307 version 6.4.1 software for the model 3510 programmer which enables v-v timing, af suppres
538 Bytes
2020-03-03
11
0
-
DevicePMAs@therightstef
P960013_S025
Approval for the optisense model 1699t and 1699tc leads. the device, as modified, will be marketed under the trade name optisense model 1699t and 1699tc leads and are designed for permanent sensing an
575 Bytes
2020-03-03
11
0
-
DevicePMAs@therightstef
P830045_S094
Approval for modifications to the epic ii/epic ii+ and epic ii hf devices. The modifications include adding a vibratory patient notifier; modifying the electrogram morphology algorithm; modifying the
1.6 KB
2020-03-03
11
0
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DevicePMAs@therightstef
P980035_S549
Approval for an update to the indications for use to include pacing at the bundle of His. The device, as modified, will be marketed under the trade name SelectSecure MRI SureScan Lead Model 3830 and i
459 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P970034_S000
Indicated for the visual correction of aphakia in persons 60 years of age or older, who are undergoing extracapsular cataract extraction and primary lens implantation. The intraocular lens is intende
439 Bytes
2020-03-03
11
4
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DevicePMAs@therightstef
P080004_S013
Approval for the model 731 intraocular lens (iol), which adds acontrolled positive spherical aberration to the optic. the device, as modified, will be marketed under the trade name isert gemetric and
368 Bytes
2020-03-03
11
0
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