FDA NEW PRODUCTS
The U.S. Food & Drug Administration’s list of pre-market approvals granted in February 2015 Summary of PMA Originals & Supplements Approved Originals: 2 Supplements: 62
Summary of All PMA Submissions Originals: 4 Supplements: 78
Summary of PMA Originals Under Review Total Under Review: 62 Total Active: 29 Total On Hold: 33
Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 62 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 148.0 FDA Time: 116 Days MFR Time: 32.0 Days
Summary of PMA Supplements Under Review Total Under Review: 556 Total Active: 430 Total On Hold: 126
PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME
COMPANY NAME CITY, STATE, & ZIP
DEVICE DESCRIPTION / INDICATIONS
P130023 2/3/15
TissuGlu® Surgical Adhesive
Cohera Medical, Incorporated Pittsburg, PA 15212
Approval for the TissuGlu® Surgical Adhesive. This device is indicated for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty.
P140018 2/20/15
VenaSeal Closure System
Covidien, LLC Morrisville, NC 27560
Approval for the VenaSeal Closure System. This device is indicated for the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular embolization with coaptation. VenaSeal is intended for use in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS).
PMA Supplemental Approvals
34
APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME
COMPANY NAME CITY, STATE, & ZIP
P850064/S027 2/13/15 180-Day
Life Pulse® High Frequency Ventilator
Bunnell, Inc. Salt Lake City, UT 84115
Approval for a new patient box for the device.
P860003/S077 2/3/15 Real-Time
THERAKOS® UVAR XTS® Photopheresis System Procedural Kits
Therakos, Inc. Bridgewater, NJ 08807
Approval for a change in the polypropylene material used for the effluent tube of the centrifuge bowls in the UVAR XTS® Photopheresis System Procedural Kits.
Medical Design & Outsourcing
FDA_JUNE 2015_Vs6.indd 34
6 • 2015
DEVICE DESCRIPTION / INDICATIONS
www.medicaldesignandoutsourcing.com
5/22/15 12:49 PM