age_PMA_annotations  

Documents (2,258) JSON TSV

source DB source ID text size updated at # proj. # Ann. updated_at
DevicePMAs@therightstef P010001_S000 Approval for the ceramic transcend hip articulation system. The device is indicated for primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease s 293 Bytes 2020-03-03 13 0
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DevicePMAs@therightstef P970062_S000 Approval for the Genestone 190 Lithotripter. This device is indicated for use in the non-invasive fragmentation of kidney (renal pelvic and renal calyceal) and upper ureteral stones between 5 and 20m 210 Bytes 2020-03-03 13 0
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DevicePMAs@therightstef P050045_S000 Approval for the top2a fish pharmdx kit. The device is indicated for: top2a fish pharmdx kit is designed to detect amplifications and deletions (copy number changes) of the top2a gene using fluoresce 566 Bytes 2020-03-03 13 0
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DevicePMAs@therightstef P060038_S026 Approval for minor design modifications to the mitroflow aortic pericardial heart valve model dl, namely the addition of radiographic markers on the sewing ring and addition of visible markers on the 447 Bytes 2020-03-03 11 0
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DevicePMAs@therightstef P990004_S012 Approval for the addition of clinical results to the product labeling with an update to the directions for use to allow use in endoscopic nasal sinus surgery and addition of a bendable applicator tip 394 Bytes 2020-03-03 11 0
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DevicePMAs@therightstef P100017_S000 The approval of realtime hcv, abbott realtime hcv amplification reagent kit, abbott realtime hcv control kit, abbott realtime hcv calibrator kit, and optional ung uracil-n-glycosylase (ung) for use in 1.92 KB 2020-03-03 13 0
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DevicePMAs@therightstef P970020_S004 Approval for the ACS Multi-Link RX Duet(TM) and ACS Multi-Link OTW Duet(TM) Coronary Stent Systems. These devices are indicated for improving coronary luminal diameter in patients with symptomatic is 375 Bytes 2020-03-03 11 0
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DevicePMAs@therightstef P060034_S000 Approval for the bio-rad monolisa anti-hbc igm eia. The device is indicated for: the bio-rad monolisa anti-hbc igm eia is an enzyme immunoassay intended for use in the qualitative detection of igm a 513 Bytes 2020-03-03 11 0
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DevicePMAs@therightstef P140015_S000 Approval for the t: slim g4 insulin pump with dexcom g4 platinum cgm (t: slim g4 system). this device consists of the t: slim g4 insulin pump paired with the dexcom g4 platinum sensor and transmitter. 1.35 KB 2020-03-03 13 0
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DevicePMAs@therightstef P020047_S022 Approval for the 2.25mm diameter stent size as part of the multi-link 8 coronary stent system. The device, as modified, will be marketed under the trade name multi-link 8 sv coronary stent system and 419 Bytes 2020-03-03 11 0
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