PMA_age_indications

Documents (2,236) JSON TSV

source DB	source ID	text	size	updated at	# proj.	updated_at
DevicePMAs@therightstef	P910023_S047	Approval for the photon(tm) dr icd system programmer software, model ac-ip is-1 receptable plug, and model 442-2 torque driver/torque wrench. The device is indicated for use in patients with a histor	821 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P980023_S000	Approval for the Phylax Implantable Cardioverter Defibrillator (ICD) System: a) ICD PUlse Generator - Phylax XM ICD, model number 121491; Phylax XM Active Housing ICD, model number 121492; Phylax XM R	1.5 KB	2020-03-03	11	-
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	-
DevicePMAs@therightstef	P970024_S000	The device is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: 1) Survival of at least one episode of	367 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P950022_S027	Approval for: 1) modifications to the riata st models 7000, 7001 and 7002 active-fixation defibrillation leads to change the geometric profile of the inner coil and add white pigment to the medical ad	920 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P900061_S047	Approval for modifications to the connector modules and connector assembly. The device, as modified, will be marketed under the trade name gem vr models 7227 b/d/e/cx and is indicated for use in pati	521 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P980016_S039	Approval for the model 2490e carelink monitor and model 2491 ddma software to allow their use with the maximo dr/vr, models 7278 & 7232 and insync ii marquis, model 7289 devices. The carelink system	374 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P920015_S024	Approval for the medtronic sprint quattro secure model 6947 lead. The device is indicated for single long-term use in the right ventricle. This lead has application for patients in which arrhythmia	233 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P920015_S039	Approval for a single-defibrillation-coil version of the fda approved sprint quattro model 6947 dual-defibrillation ?coil active-fixation right ventricular lead. The device, as modified, will be mark	380 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P910023_S065	Approval for the epic plus dr/vr device with model 3307 version 4.3a programmer software. The device, as modified, will be marketed under the trade name st. jude medical epic plus vr/dr implantable c	707 Bytes	2020-03-03	11	-