Medtech approvals: FDA releases May 2015 PMAs

The FDA today released its list of the pre-market approvals it granted for medical devices in May 2015: Summary of PMA Originals & Supplements Approved Originals: 5 Supplements: 51 Summary of PMA Originals Under Review Total Under Review: 55 Total Active: 26 Total On Hold: 29 Summary of PMA Supplements Under Review Total Under Review: 547 Total Active: 379 Total On Hold: 168 Summary of All PMA Submissions Originals: 1 Supplements: 62 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 51 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 109.5 FDA Time: 86.4 Days MFR Time: 23.1 Days PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS P130022 5/8/15 Nevro Senza Spinal Cord Stimulation (SCS) System Nevro Corporation Menlo Park, CA 94025 Approval for the Nevro Senza SCS System. This device is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain, and leg pain. P140002 5/22/15 Misago Peripheral Self-Expanding Stent System Terumo Medical Corporation Elkton, MD 21921 Approval for the Misago Peripheral Self-expanding Stent System. This device is indicated to improve luminal diameter in symptomatic patients with de novo or restenotic native lesions or oc...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news