UroLift® System FAQs | 合法醫療器材資訊網

YourdoctorwillusetheUroLiftDeliveryDevicetodeploypermanentimplantstorelieveobstructioncausedbytheenlargedprostatethatispressingonyour ...

Non-clinical testing has demonstrated that the UroLift Implant is MR Conditional. A patient with this device can be safely scanned in an MR system immediately after placement meeting the following conditions:

Static magnetic field of 3.0 Tesla or less Maximum spatial field gradient of 1,500 Gauss/cm (15 T/m) (extrapolated) Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg for 15 minutes of continuous scanning (i.e., per pulse sequence) (First Level Controlled Operating Mode)

Under the scan conditions defined above, the UroLift Implant is expected to produce a maximum temperature rise of 2.4°C after 15 minutes of continuous scanning (i.e., per pulse sequence)

In non-clinical testing, the image artifact caused by the device extends approximately 15 mm from the UroLift Implant when imaged with a gradient echo pulse sequence a...

De Novo Summary (K130651) Page 1 FDA identifies this ... | 合法醫療器材資訊網

The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 ... Read More

DEC 2 0 2013 | 合法醫療器材資訊網

2020年12月2日 — The UroLift System is intended for the treatment of symptoms due to urinary ... Table 11-6 Effect of the Modified UroLift System on FDA Identified ... Read More

K200441 TradeDe | 合法醫療器材資訊網

2020年6月5日 — Trade/Device Name: UroLift Advanced Tissue Control (ATC) System ... at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm ... Read More

UroLift® | 合法醫療器材資訊網

The UroLift System is an FDA Cleared, revolutionary minimally invasive treatment of Benign Prostatic Hyperplasia (BPH) or an enlarged prostate. Read More

Teleflex Announces FDA Clearance for Expanded ... | 合法醫療器材資訊網

2020年1月7日 — The FDA-cleared UroLift System is a proven, minimally invasive technology for treating lower urinary tract symptoms due to benign prostatic ... Read More

UroLift® System FAQs | 合法醫療器材資訊網

Your doctor will use the UroLift Delivery Device to deploy permanent implants to relieve obstruction caused by the enlarged prostate that is pressing on your ... Read More

UroLift® Peer Reviewed Clinical Results | 合法醫療器材資訊網

UroLift System Treatment Delivers a Superior Patient Experience: · Rapid relief and recovery · Lowest catheter rate of the leading BPH procedures · No new, ... Read More

About UroLift® | 合法醫療器材資訊網

The UroLift System uses a revolutionary approach to treating BPH that lifts and holds the enlarged prostate tissue out of the way so it no longer blocks the ... Read More

Teleflex's UroLift wins new FDA designation | 合法醫療器材資訊網

2020年1月7日 — Teleflex's UroLift wins new FDA designation ... Teleflex (NYSE:TFX) said today that the FDA has granted the company an expanded indication for ... Read More

NeoTract | 合法醫療器材資訊網

NeoTract, Inc. Receives U.S. FDA De Novo Approval for the UroLift® Prostate Implant. Breakthrough Technology Approved for Treatment of BPH Delivers ... Read More

相關資訊整理

De Novo Summary (K130651) Page 1 FDA identifies this ... | 合法醫療器材資訊網

DEC 2 0 2013 | 合法醫療器材資訊網

K200441 TradeDe | 合法醫療器材資訊網

UroLift® | 合法醫療器材資訊網

Teleflex Announces FDA Clearance for Expanded ... | 合法醫療器材資訊網

UroLift® System FAQs | 合法醫療器材資訊網

UroLift® Peer Reviewed Clinical Results | 合法醫療器材資訊網

About UroLift® | 合法醫療器材資訊網

Teleflex&#39;s UroLift wins new FDA designation | 合法醫療器材資訊網

NeoTract | 合法醫療器材資訊網

Teleflex's UroLift wins new FDA designation | 合法醫療器材資訊網