PMA_age_indications

Documents (2,236) JSON TSV

source DB	source ID	text	size	updated at	# proj.	updated_at
DevicePMAs@therightstef	P910073_S043	Approval for addition of an eptfe coating to the shock coils. The device, as modified, will be marketed under the trade name endotak reliance g/sg lead models and is indicated for providing pacing an	335 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P950022_S024	Approval for addition of the riata st lead models 7000, 7001, and 7002 to the riata defibrillation lead system. The devices, as modified, will be marketed under the trade name riata st models 7000, 7	273 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P980016_S389	Approval for clarifications to the indications for use statements related to the optivol feature and other modifications to the device labeling. the devices are indicated as follows: dual chamber icd	1.44 KB	2020-03-03	11	-
DevicePMAs@therightstef	P910023_S000	Approval for the Cadence Tiered Therapy Defibrillator System. This device is indicated for use in patients with a history of hemodynamically compromising ventricular tachyarrhythmias. These patients	1012 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P950022_S017	Approval for the addition of a fluoroscopic marker in the helix tip and the addition of new lead lengths and minor modifications to the suture sleeve. The leads are indicated for permanent sensing an	297 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P900061_S050	Approval for the general use indication for implantable cardioverter defibrillator models 7227cx, 7227b, 7227d and 7227e and are indicated to provide ventricular antitachycardia pacing and ventricular	284 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P110042_S000	Approval for the subcutaneous implantable defibrillator (s-icd) system. this device is indicated to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in	402 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P980016_S029	Approval for medtronic models 7230cx, 7230b, and 7230e marquis vr single chamber implantable cardioverter defibrillator (icd) systems with model 9967 (marquis vr) application software for use with the	885 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P950022_S014	Approval for new defibrillation lead systems and accessories. The devices, as modified, will be marketed under the trade name riat series 1500 (models 1570, 1571, 1580 and 1581) defibrillation lead s	493 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P910023_S043	Approval for the transtelephonic follow-up system. The device, as modified, will be marketed under the trade name Housecall(TM) 2.0 system and is indicated for use with the Ventritex(R) Tiered-Therap	217 Bytes	2020-03-03	11	-