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Medtech approvals: FDA releases June 2015 PMAs

The FDA today released its list of the pre-market approvals it granted for medical devices in June 2015: Summary of PMA Originals &Supplements Approved Originals: 5 Supplements: 80 Summary of PMA Originals Under Review Total Under Review: 53 Total Active: 22 Total On Hold: 31 Summary of PMA Supplements Under Review Total Under Review: 575 Total Active: 418 Total On Hold: 157 Summary of All PMA Submissions Originals: 4 Supplements: 72 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 80 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 115.2 FDA Time: 97.1 Days MFR Time: 18.1 Days PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, &ZIP DEVICE DESCRIPTION / INDICATIONS P120024 6/11/15 activL® Artificial Disc Aesculap Implant Systems, LLC Center Valley, PA 18034 Approval for the activL® Artificial Disc. This device is indicated for reconstruction of the disc at one level (L4-L5 or L5- S1) following single-level discectomy in skeletally mature patients with symptomatic degenerative disc disease (DDD) with no more than Grade I spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. The activL® Artificial Disc is implanted using an anterior retroperitoneal approach. Patients receiving the activL® Arti...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

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