Relieva stratus microflow spacer
WebThe purpose of this study was to evaluate the effectiveness, safety and correct indication about the use of BCD and a non-absorbable stent (Relieva Stratus™ MicroFlow spacer) in … WebNov 20, 2008 · Acclarent (Menlo Park, CA), the company that originally introduced balloon sinuplasty, has developed the Relieva Stratus MicroFlow Spacer, a new device described …
Relieva stratus microflow spacer
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WebThe Relieva Stratus™ MicroFlow spacer is a balloon-based device that acts as a spacer and medication delivery system. It was FDA approved under the 510(k) program in October 2011. It is indicated for use as a postoperative spacer to maintain an opening to the sinuses within the first 14 days postoperatively. This WebNov 17, 2008 · Device: Stratus Microflow Ethmoid Spacer The Spacer is inserted surgically into the ethmoid complex through the use of a sinus access system. Triamcinolone …
WebRelieva Stratus™ MicroFlow Spacer Acclarent, Inc. 1525-B O’Brien Drive Menlo Park, CA 94025 U.S.A. 1-877-SPLASTY (1-877-775-2789) 1-650-687-5888 1-650-687-5886 …
WebFacteau and Fabian helped build Acclarent into a company that was acquired by J&J for $785 million in 2010, but prosecutors claimed the company along the way was engaged in so-called off-label promotion of Relieva Stratus Microflow Spacer sinus balloon catheters. Acclarent had received FDA clearance in 2006 to market the Stratus as a spacer, only to … WebJul 27, 2016 · Acclarent’s Relieva Stratus MicroFlow Spacer was approved by the FDA in 2006, for use as a spacer and only to be used with saline to maintain sinus openings …
WebClinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide (Kenalog-40) Study Start Date : Aug 1, 2008. Actual Primary Completion Date : …
WebFeb 21, 2024 · To evaluate whether an ethmoidal drug-eluting stent (DES) (the Relieva Stratus™ MicroFlow Spacer) could better prevent endoscopic sinus surgery (ESS) than … bubble toy font free downloadWebPredicate Device: Relieva Stratus MicroFlow Spacer (K093594) Device Description: The Relieva Stratus Pro MicroFlow Spacer (Frontal) is a device that maintains an opening at … exposure to trichloroethylene veteransWebTrade Name: Relieva Stratus MicroFlow Spacer Common Name: Frontal Sinus Spacer Indications For Use: The MicroFlow Spacer (Frontal) is indicated for use as a postoperative spacer to maintain an opening to the frontal sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction. bubble toyWebApr 21, 2024 · In 2016, two Acclarent executives were convicted of ten misdemeanor counts for marketing a medical device known as Relieva Stratus MicroFlow Spacer (Stratus; Acclarent) as a steroid delivery device despite prior rejection by the FDA for this indication . bubble town shooter free onlineWebClinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide (Kenalog-40) Study Start Date : Aug 1, 2008. Actual Primary Completion Date : Nov 1, 2011. Actual Study Completion Date ... Stratus Microflow Ethmoid Spacer: ... bubble town westWebRELIEVA STRATUS MICROFLOW SPACER: Type of Device: STRATUS FRONTAL SPACER: Manufacturer (Section D) ACCLARENT INC: menlo park CA : Manufacturer Contact: monica barrett 1525-b o'brien dr. menlo park, CA 94025 6506874948 MDR Report Key: 3145414: MDR Text Key: 10792617: Report Number: exposure to typhoonWebJul 22, 2016 · Acclarent sold a variety of medical devices used in sinus surgeries, including a device known as the Relieva Stratus MicroFlow Spacer (Stratus). In 2006, Acclarent … exposure to type a flu