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> DevicePMAs@therightstef
PMA_age_indications
Documents
(2,236)
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DevicePMAs@therightstef
P030040_S011
Approval for a claim to test a pediatric population with the FDA approved ADVIA Centaur HBc IgM Read
2.61 KB
2020-03-03
11
21
-
DevicePMAs@therightstef
P000025_S021
Approval for the sonatati100 cochlear implant and is indicated for the following patient populations
1.52 KB
2020-03-03
11
20
-
DevicePMAs@therightstef
P000025_S000
Approval for the med-el combi 40+ cochlear implant system (combi 40+). The device is intended to pr
1.86 KB
2020-03-03
11
20
-
DevicePMAs@therightstef
P000025_S033
Approval for the use of an alternative hybrid component in the manufacture of the sonatati100 cochle
1.7 KB
2020-03-03
11
19
-
DevicePMAs@therightstef
P190016_S000
Approval for the Tula System. This device is intended to create a myringotomy and insert a tympanos
1.18 KB
2020-03-03
13
18
-
DevicePMAs@therightstef
P980022_S015
Approval for the paradigm real-time and guardian real-time systems. The guardian real-time system i
1.67 KB
2020-03-03
11
18
-
DevicePMAs@therightstef
P020050_S006
Approval for increased pulse frequency from 400 to 500 hz, a new laser head, a new housing with grea
1.94 KB
2020-03-03
13
16
-
DevicePMAs@therightstef
P030008_S006
Approval for increased pulse frequency from 400 to 500 hz, a new laser head, a new housing with grea
1.94 KB
2020-03-03
11
16
-
DevicePMAs@therightstef
P930027_S004
Immulite psa, immulite. third generation psa, immulite 2000 psa, and immulite 2000 third generation
1.35 KB
2020-03-03
13
16
-
DevicePMAs@therightstef
P170002_S000
Approval for the RH-2. The RHA 2 is indicated for injection into the mid-to-deep dermis for the cor
664 Bytes
2020-03-03
11
15
-
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