med-device

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	updated_at
DevicePMAs@therightstef	P120005_S028	For the addition of a bluetooth low energy (ble) radio to both theadult (mt20649) and pediatric (mt22430) versions of the dexcom g4 platinum receiver,identified as the dexcom g4 platinum receiver with	1.3 KB	2020-03-03	11	-
DevicePMAs@therightstef	P810032_S050	Approval to modify the indications statement, to indicate the iols for use in adult patients following cataract surgery. Previously, the iols were indicated for use in persons 60 years of age or olde	464 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P960016_S008	Approval for revised indications for use for livewire tc ablation catheters. The catheters are indicated for cardiac electrophysiological mapping and for use with a compatible rf generator for creati	279 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P970004_S009	Approval for the model 3095a lead extension kit for use with the medtronic(r) interstim(r) system for urinary control, which is indicated for the treatment of urinary urge incontinence, urinary retent	330 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P960043_S046	Approval for various dimensional changes which result in a larger version of the original device. The device, as modified, will be marketed under the trade name closer xl suture mediated closure (smc	425 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P940008_S000	Approval application (pma) for the res-q acd (arrythmia control device) epicardial patch and non-thoracotomy lead (ntl) systems which consist of the following: model 101-01 & 101-01r res-q implantabl	1.29 KB	2020-03-03	11	-
DevicePMAs@therightstef	P820033_S005	Approval for the plasmaflo op-05w(a). The device, is intended as a replacement for the plasmaflo ap-05h and the plasmaflo ap-05h(l). The device will be marketed under the trade name plasmaflo op-05w	303 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P830037_S048	Approval for the freshlook dimensions (phemfilcon a) soft (hydrophilic) contact lens indicated for extended wear up to 6 nights/7 days. This device will be an optimized combination of two of the prev	1.95 KB	2020-03-03	11	-
DevicePMAs@therightstef	P020011_S005	Approval for a device name change. the device, as modified, will be marketed under the trade name versant hcv rna qualitative assay and aptima hcv rna qualitative assay and is indicated for the detect	308 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P140008_S013	Approval for the ORBERA Intragastric Balloon System. The device is indicated for use as an adjunct to weight reduction for adults with obesity with Body Mass Index (BMI) of >= 30 and <= 40 kg/m2 and	633 Bytes	2020-03-03	13	-