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® Artificial Disc sh...
Source: Mass Device - Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
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