age_PMA_annotations  

Documents (2,258) JSON TSV

source DB source ID text size updated at # proj. # Ann. updated_at
DevicePMAs@therightstef P100039_S000 Approval for advia centaur anti-hbs2 (ahbs2) assay and advia centaur anti-hbs2 (ahbs2) quality control material for use on the advia centaur and advia centaur xp systems. This device is indicated for 1.44 KB 2020-03-03 11 0
-
DevicePMAs@therightstef P150034_S000 Approval for the Raindrop Near Vision Inlay. This device is indicated for intrastromal implantation to improve near vision in the non-dominant eye of phakic, presbyopic patients, 41 to 65 years of age 479 Bytes 2020-03-03 13 0
-
DevicePMAs@therightstef P100032_S007 Approval for the migration of claims from the fda approved elecsys anti-hbc immunoassay and elecsys precicontrol anti-hbc on the elecsys 2010 analyzer to the cobas e 411 immunoassay analyzer. the devi 1.27 KB 2020-03-03 11 0
-
DevicePMAs@therightstef P970008_S001 Approval for a change in trade name. The device will be marketed under the trade anme Urologix Targis(TM) system and is indicated to relieve symptoms associated with benign prostatic hyperplasia (BPH 257 Bytes 2020-03-03 13 0
-
DevicePMAs@therightstef P880003_S089 Approval for a new catheter model. The device, as modified, will be marketed under the trade name dura star rx ptca balloon dilatation catheter and is indicated for balloon dilatation of the stenotic 432 Bytes 2020-03-03 11 0
-
DevicePMAs@therightstef P020036_S000 Approval for the s. m. a. r. t. nitinol stent system and s. m. a. r. t. control nitinol stent system. The devices are indicated for improving luminal diameter in patients with symptomatic atheroscler 407 Bytes 2020-03-03 11 0
-
DevicePMAs@therightstef P860057_S056 Approval for a new device trade name and model number to add to the carpentier-edwards perimount pericardial bioprosthesis family. Model 7200tfx is identical to the previously approved model 7000tfx 575 Bytes 2020-03-03 11 0
-
DevicePMAs@therightstef P970035_S000 Approval for the AVE Micro Stent(TM) II Over-the-Wire Coronary Stent System and the AVE GFX(TM) Over-the-Wire Coronary Stent System. The devices are indicated for use in patients eligible for balloon 561 Bytes 2020-03-03 11 0
-
DevicePMAs@therightstef P010059_S000 Approval for the morcher capsular tension ring, types 14, 14a and 14c. The device is indicated for the stabilization of the crystalline lens capsule in the presence of weak or partially absent zonule 552 Bytes 2020-03-03 13 0
-
DevicePMAs@therightstef P040004_S002 Approval for the transition of the advia centaur hbc total assay to a new platform in the centaur family of instruments, the centaur cp. the device, as modified, will be marketed under the trade name 1.33 KB 2020-03-03 11 0
-