Medtech approvals: FDA releases November 2015 PMAs

The FDA today released its list of the pre-market approvals it granted for medical devices in November 2015: Summary of PMA Originals &Supplements Approved Originals: 3 Supplements: 69 Summary of PMA Originals Under Review Total Under Review: 57 Total Active: 30 Total On Hold: 27 Summary of PMA Supplements Under Review Total Under Review: 583 Total Active: 433 Total On Hold: 150 Summary of All PMA Submissions Originals: 4 Supplements: 75 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 69 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 193.4 FDA Time: 103.0 Days MFR Time: 90.4 Days PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, &ZIP DEVICE DESCRIPTION / INDICATIONS P130018 11/24/15 ProACT™ Adjustable Continence Therapy for Men Uromedica, Inc. Plymouth, MN 55441 Approval for the ProACT Adjustable Continence Therapy for Men. This device is indicated for the treatment of adult men who have stress incontinence arising from intrinsic sphincter deficiency of at least twelve months duration following radical prostatectomy or transurethral resection of the prostate (TURP) and who have failed to respond adequately to conservative therapy. P130028 11/20/15 Algovita Spinal Cord Stimulation System Algostim, LLC Blaine, MN 55449 Approval for the Algovita Spinal Cord Stimulation System. This device is indicated as an aid in the management ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

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In this study, the slide wear characteristics and the coefficient of friction of HDPE (high density polyethylene) containing bi-directional silk fiber (SF) composites at two levels of nanoclay (0.5 and 1.%NC) are experimentally investigated using pin on disc setup for three sliding distance. It is observed from slide wear data that increasing the sliding distance, the weight loss increases for pure HDPE, pure HDPE+SF, pure HDPE+SF+0.5%NC and pure HDPE+SF +1%NC of the load application of 10N,20N,30N respectively. Also among four samples studied, the pure HDPE+SF +1%NC shows the least weight loss and pure HDPE shows highest....
Source: Materials Today: Proceedings - Category: Materials Science Source Type: research
Publication date: 2018Source: Materials Today: Proceedings, Volume 5, Issue 11, Part 3Author(s): S. Muzzamil Ahamed, S.G. Rakesh, Y. Vijaya Kumar, B. Mahboob Tabrez, V. Bharat, Mohammed ZakaullaAbstractThe presentation in this paper briefs the experimental results obtained for evaluating the hardness and comparing with its microstructural pattern. Mild steel chills (MSC) are used to check the chilling effect. The results show that chill position influences the hardness of cast iron. Increase in hardness is observed by placing MSC at different locations. Specimens were prepared for microstructural examination using scanning...
Source: Materials Today: Proceedings - Category: Materials Science Source Type: research
Publication date: 2018Source: Materials Today: Proceedings, Volume 5, Issue 11, Part 3Author(s): Aswin G. Nath, E. Sarath Krishnan, Sachin Cheriyan, P.S. Vishnu, A. Krishnan, Pramod Sreedharan, Ganesha UdupaAbstractA miniaturize hydraulic gear pump is used for pressure generation in the fluidic actuators used in some of the medical and bio-medical devices such as blood pressure monitoring devices, artificial heart pump and prosthetic hands. A large variety of sizes of hydraulic pumps is commercially available. Proper design of the pump depends significantly on the application. Various designs of miniature hydraulic pumps h...
Source: Materials Today: Proceedings - Category: Materials Science Source Type: research
In this study, PP/Nylon 6 blend ratio was maintained at 70/30. In addition to the compatibilizer, carboxylic acid functionalized multi walled carbon nanotubes (MWCNT) were added to the blend. The polymer blend prepared by twin screw extrusion was converted into test samples by injection moulding. The microstructure development of the blends was characterized by scanning electron microscopy (SEM) and fourier transform infrared spectroscopy (FTIR) techniques. The mechanical and thermal properties of the blends were studied using tensile test and differential scanning calorimetry (DSC) respectively. The effective dispersion o...
Source: Materials Today: Proceedings - Category: Materials Science Source Type: research
Publication date: 2018Source: Materials Today: Proceedings, Volume 5, Issue 11, Part 3Author(s): Sagar M Baligidad, U Chandrasekhar, K Elangovan, S Shankar, N Anjankumar, J SupriyaAbstractSelective Inhibition Sintering (SIS) is emergent rapid prototyping technology that builds the solid parts by fusing the powder particles layer by layer with heat, directly from CAD model. The SIS process has many processing parameters of which some have a direct effect on the mechanical properties of the parts fabricated. The HDPE powder particle size was characterized by scanning electron microscopy, differential scanning calor...
Source: Materials Today: Proceedings - Category: Materials Science Source Type: research
Publication date: 2018Source: Materials Today: Proceedings, Volume 5, Issue 11, Part 3Author(s): K. Naresh, K. Shankar, R. VelmuruganAbstractImpact resistance (energy absorption) is the needful information for any engineering material which has been used for vehicles to reduce the fatal accidents. The present study focuses to investigate the behavior of unidirectional glass fiber reinforced plastic (GP) composites of different orientations [0°, 45°, [45°/-45°/45°]s, [±45°/0°/90°]s and 90°] under tensile and impact loading. The new laminate orientation ([45°/-45°/45°]s)...
Source: Materials Today: Proceedings - Category: Materials Science Source Type: research
Publication date: 2018Source: Materials Today: Proceedings, Volume 5, Issue 11, Part 3Author(s): S. Shashidhar, P. Vijaya Kumar, M. Shantharaja, Madeva Nagaral, B.K. ShivanandaAbstractMetal matrix composites are considered as advanced materials in the field of automotive, marine and several industrial applications. In the present work investigations have been made on effect of nano B4C particulates addition on the tensile behavior of Al2219 alloy. Nano B4C particulates of 500nm were used as the reinforcements in the Al alloy matrix. Nano composites were synthesized by using liquid melt method in steps of 2 and 4 wt. % in t...
Source: Materials Today: Proceedings - Category: Materials Science Source Type: research
The objective of this study is to investigate the influence of nano-sized graphite on the mechanical, thermal and wear characteristics of Ultra High Molecular Weight Polyethylene (UHMWPE) - Graphite (Nano 27) nanocomposites. Mechanical, wear and thermal properties were analyzed for nanocomposites containing 0.5, 1, 1.5 and 2% graphite and compared with unfilled UHMWPE. The wear properties of the nanocomposites were modeled and optimized for nano-graphite content and process parameters viz. sliding velocity and load. Response surface methodology (RSM) was utilized for modeling and optimization for reducing the wear rate in ...
Source: Materials Today: Proceedings - Category: Materials Science Source Type: research
This study establishes silazane modified phenol formaldehyde as a potential preceramic matrix resin for the fabrication of Cf/PyC/SiC-Si3N4 composites to achieve improved mechanical properties for thermo-structural applications.
Source: Materials Today: Proceedings - Category: Materials Science Source Type: research
Publication date: 2018Source: Materials Today: Proceedings, Volume 5, Issue 11, Part 3Author(s): K.S. Pujari, D.V. Patil, Gurunath MewundiAbstractGas tungsten arc welding (GTAW) quality is mainly characterized by the weld pool geometry. This is because the weld pool geometry is highly influential in determining the mechanical properties of the weld joint. In this paper, the selection of process parameters for obtaining optimal weld pool geometry in the GTAW of AA 7075-T6 aluminium alloy is presented. Taguchi method is stastical tool widely using to optimize process parameters as a single response problem. The single respon...
Source: Materials Today: Proceedings - Category: Materials Science Source Type: research
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