> top > projects > PMA_MER > docs
PMA_MER  

Documents (2,258) JSON TSV

source DB source ID text size updated at # proj. # Ann. updated_at
DevicePMAs@therightstef P030012_S000 Approval for the imagechecker ct cad software system - model ln-1000. This software system is indicated to assist radiologists in the detection of solid pulmonary nodules during review of multidetect 419 Bytes 2020-03-03 13 13
-
DevicePMAs@therightstef P110024_S000 Approval for the resqcpr system. this device is indicated for use as a cpr adjunct to improve the likelihood of survival in adult patients with non-traumatic cardiac arrest. 173 Bytes 2020-03-03 13 6
-
DevicePMAs@therightstef P060028_S000 Approval for thememoryshape breast implants. this device is indicated for females for the following uses(procedures):1) breast augmentation for women at least 22 years old. breast augmentation include 716 Bytes 2020-03-03 13 29
-
DevicePMAs@therightstef P120021_S000 Approval for the AMPLATZER PFO Occluder. The device is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, pr 438 Bytes 2020-03-03 13 12
-
DevicePMAs@therightstef P120019_S019 Approval for the cobas EGFR Mutation Test v2. The device is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small ce 2.41 KB 2020-03-03 13 94
-
DevicePMAs@therightstef P120014_S000 Approval for the thxid braf kit for use on the abi 7500 fast dx real-time pcr instrument. this device is indicated for: the thxid braf kit is an in vitro diagnostic device intended for the qualitative 705 Bytes 2020-03-03 13 22
-
DevicePMAs@therightstef P950015_S000 Approval for The Heart Laser CO2 TMR System. This device is indicated for the treatment of patients with stable angina (Canadian Cardiovascular Society class 3 or 4) refractory to medical treatment a 323 Bytes 2020-03-03 13 21
-
DevicePMAs@therightstef P830060_S000 Approval for the Automatic Implantable Cardioverter Defibrillator (AICD). The device is indicated for the treatment of ventricular tachycardia and ventricular fibrillation in those patients who are a 855 Bytes 2020-03-03 11 35
-
DevicePMAs@therightstef P160052_S000 Approval for the PartoSure test. The device is a rapid, qualitative test for detecting the presence of placental alpha microglobulin 1 (PAMG-1) in cervicovaginal secretions. The device is indicated a 564 Bytes 2020-03-03 13 18
-
DevicePMAs@therightstef P150011_S000 Approval for the Perceval Sutureless Heart Valve. This device is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. 170 Bytes 2020-03-03 11 5
-