PMA_MER

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	# Ann.	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	36	-
DevicePMAs@therightstef	P910023_S061	Approval for a downsized version of the photon udr/vr device. The device, as modified, will be marketed under the trade name st. jude medical epic vr/dr implantable cardioverter defibrillators (model	380 Bytes	2020-03-03	10	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	101	-
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	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	18	-
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	22	-
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	20	-
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	16	-
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	13	-
DevicePMAs@therightstef	P910077_S026	Approva for a switchable ECG cable that allows the clinician to display and record ECG signals from seven different vectors (leads) without moving the ECG electrodes that are attached to the patient.	401 Bytes	2020-03-03	10	9	-