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PMA_age_indications
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PMA_age_indications
Documents
(2,236)
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# proj.
# Ann.
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DevicePMAs@therightstef
P990071_S013
Approval for the following modifications: 1) reduced recommended saline flow rate (reduce by ~50%; 2
1.36 KB
2020-03-03
13
6
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DevicePMAs@therightstef
P120010_S046
Approval for the minimed 530g system with threshold suspend featuring smartguard technology. this de
1.74 KB
2020-03-03
13
4
-
DevicePMAs@therightstef
P140021_S005
Approval for the migration of claims from the FDA approved Elecsys Anti-HCV II Immunoassay and Elecs
1.29 KB
2020-03-03
11
7
-
DevicePMAs@therightstef
P930016_S057
Approval for the STAR S4 IR Excimer Laser System and iDESIGN Refractive Studio. This device is indi
868 Bytes
2020-03-03
13
4
-
DevicePMAs@therightstef
P990027_S006
Approval for the bausch & lomb technolas 217z zyoptix system for personalized vision correction. Th
704 Bytes
2020-03-03
11
4
-
DevicePMAs@therightstef
P030008_S017
Approval to expand the approval of the topolyzer vario to include its use as a diagnostic device sup
1.02 KB
2020-03-03
11
4
-
DevicePMAs@therightstef
P140021_S000
Approval for the elecsys anti-hcv ii immunoassay and elecsys precicontrol anti-hcv. this device is i
1.06 KB
2020-03-03
11
7
-
DevicePMAs@therightstef
P160017_S031
Approval for the MiniMed 670G System. The Medtronic MiniMed 670G system is intended for continuous
3.43 KB
2020-03-03
13
4
-
DevicePMAs@therightstef
P000025_S084
Approval for expanding the indications to include the Electro-acoustic Stimulation (EAS) system that
1.32 KB
2020-03-03
13
4
-
DevicePMAs@therightstef
P050006_S060
Approval for the GORE CARDIOFORM Septal Occluder. The GORE CARDIOFORM Septal Occluder is a permanen
605 Bytes
2020-03-03
13
4
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