PMA_Manual

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	updated_at
DevicePMAs@therightstef	P190016_S000	Approval for the Tula System. This device is intended to create a myringotomy and insert a tympanostomy tube using the Tula Tube Delivery System in pediatric (aged 6 months and older) and adult patie	1.18 KB	2020-03-03	13	-
DevicePMAs@therightstef	P180035_S000	Approval for MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear. This device indicated for the correction of myopic ametropia and for slowing the progression of myopia in ch	464 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P030016_S001	Approval for the Visian Toric ICL (Implantable Collamer Lens). The device is indicated for use in patients 21-45 years of age: 1) for the correction of myopic astigmatism with spherical equivalent ran	890 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P970032_S000	Approval for the SalEst(TM). This device is intended to detect and measure by enzyme-linked immunoabsorbant assay (ELISA) technology the level of salivary estriol in pregnant women. The device is in	504 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P010061_S000	Approval for the curelight broadband (model curelight 01). The device is indicated for use in combination with tradename cream for treatment of non-hyperkeratotic actinic keratoses of the face and sc	429 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P170027_S000	Approval for the TherOx Downstream System. This device is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patien	520 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P940001_S000	This device indicated for delivering arbutamine, a catecholamine, through a closed-loop, computer-controlled drug-delivery system to elicit acute cardiovascular responses similar to those produced by	1.75 KB	2020-03-03	13	-
DevicePMAs@therightstef	P960009_S219	Approval to expand the indications for the Medtronic DBS system to include Epilepsy. Bilateral stimulation of the anterior nucleus of the thalamus (ANT) using the Medtronic DBS System for Epilepsy is	837 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P180050_S000	Approval for The BAROSTIM NEO System. The device is indicated for the improvement of symptoms of heart failure. quality of life, six-minute hall walk and functional status, for patients who remain sy	529 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P160048_S006	Approval for the Eversense CGM System. The device is indicated for continually measuring glucose levels in adults (age 18 and older) with diabetes for up to 90 days. The system is indicated for use t	765 Bytes	2020-03-03	13	-