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PMA_age_indications
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PMA_age_indications
Documents
(2,236)
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DevicePMAs@therightstef
P990026_S000
Approval for the glucowatch(r) automatic glucose biographer. The device is indicated for: the gluco
876 Bytes
2020-03-03
13
4
-
DevicePMAs@therightstef
P080028_S000
Approval for the storz medical duolith sd1 shock wave therapy. this device is indicated for extracor
500 Bytes
2020-03-03
13
4
-
DevicePMAs@therightstef
P990055_S001
Approval for the addition of the assay to the bayer acs: 180 and advia centaur analyzers. The devic
634 Bytes
2020-03-03
13
4
-
DevicePMAs@therightstef
P980031_S000
This device is indicated for the reduction or elimination of mild myopia (-2.00 to -3.00 diopters sp
404 Bytes
2020-03-03
13
4
-
DevicePMAs@therightstef
P990052_S015
Approval for a change in the wording of the indications for use statement and a new product code des
402 Bytes
2020-03-03
13
5
-
DevicePMAs@therightstef
P110039_S000
Approval for the exablate system, model 2000/2100 /2100 vi. this device is indicated for pain pallia
419 Bytes
2020-03-03
13
4
-
DevicePMAs@therightstef
P990078_S000
Approval for the sunrise hyperion(tm) ltk system. The device is indicated for temporary reduction o
500 Bytes
2020-03-03
13
4
-
DevicePMAs@therightstef
P920030_S002
Approval for the addition of a new indication for use. The device, as modified, will be marketed un
485 Bytes
2020-03-03
13
4
-
DevicePMAs@therightstef
P850048_S017
Approval for the access hybritech psa on the access 2 immunoassay analyzer. The device is indicated
704 Bytes
2020-03-03
13
4
-
DevicePMAs@therightstef
P100044_S000
Approval for the propel sinus implant. This device is indicated for use in patients >= 18 years of
430 Bytes
2020-03-03
13
4
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