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 of chr...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news