age_PMA_annotations  

Documents (2,258) JSON TSV

source DB source ID text size updated at # proj. # Ann. updated_at
DevicePMAs@therightstef P900043_S028 Approval for a new indication (elective stenting of de novo and restenotic coronary arteries) and additional stent diameters (4.5 and 5.0 mm) for the bx velocity with hepacoat on stent system. The d 995 Bytes 2020-03-03 11 0
-
DevicePMAs@therightstef P040034_S000 Approval for the duraseal dural sealant system. The device is indicated for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure. Duraseal should only be us 239 Bytes 2020-03-03 13 0
-
DevicePMAs@therightstef P140012_S000 Approval for the reshape integrated dual balloon system. the reshape integrated dual balloon system is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients 402 Bytes 2020-03-03 13 0
-
DevicePMAs@therightstef P850048_S017 Approval for the access hybritech psa on the access 2 immunoassay analyzer. The device is indicated for: the access hybritech psa assay is a paramagnetic particle, chemiluminescent immunoassay for t 704 Bytes 2020-03-03 13 0
-
DevicePMAs@therightstef P010014_S000 Approval for the oxford meniscal unicompartmental knee system (phase 3). The device is indicated for use in patients with osteoarthritis or avascular necrosis limited to the medial compartment of the 252 Bytes 2020-03-03 13 0
-
DevicePMAs@therightstef P970020_S023 Approval for the acs multi-link rx and otw tetra(tm) coronary stent systems. The devices are indicated for improving coronary lumen diameter in the following: 1) patients with symptomatic ischemic d 780 Bytes 2020-03-03 11 0
-
DevicePMAs@therightstef P130015_S000 Approval for the elecsys hbeag immunoassay and elecsys precicontrol hbeag. this device is indicated for: elecsys hbeag immunoassaythe elecsys hbeag immunoassay is intended for the in vitro qualitative 901 Bytes 2020-03-03 11 0
-
DevicePMAs@therightstef P950037_S092 Approval for the ics 3000 programmer application software version psw 1004.u, and the estella dr; estella dr-t; estella sr; estella sr-t; ecuro dr; ecuro dr-t; ecuro sr; ecuro sr-t; effecta d; effecta 363 Bytes 2020-03-03 11 0
-
DevicePMAs@therightstef P840001_S185 Approval for the restoresensor rechargeable implantable neurostimulation system. the device, as modified, will be marketed under the trade name restoresensor rechargeable implantable neurostimulation 976 Bytes 2020-03-03 11 0
-
DevicePMAs@therightstef P870015_S030 Approval for a transportable configuration of the Medstone STS lithotripter. The devices, as modified, will be marketed under the trade name Medstone STS-T Transportable Lithotripter and is indicated 334 Bytes 2020-03-03 13 0
-