Category: Food & Drug Administration (FDA)
W.L. Gore touts expanded approval to market its Viabahn endoprosthesis to treat stenosis and thrombosis in synthetic vascular access grafts.
W.L. Gore & Associates today touted expanded FDA approval for its Viabahn endoprosthesis, now indicated for treatment of stenosis and thrombotic occlusions related to synthetic vascular access grafts.
The U.S. Food & Drug Administration releases a list of 510(k) clearances granted in November 2013.
TOTAL 510(k)s THIS PERIOD 224
TOTAL WITH SUMMARIES 212
TOTAL WITH STATEMENTS 12
DEVICE: PREFERRED BLOOD GLUCOSE MONITORING SYSTEM
PRODIGY DIABETES CARE, LLC 510(k) NO: K122338(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 888 729 9674
1468 HARWELL AVENUE SE DECISION MADE: 05-NOV-13
CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
C4 Imaging celebrates its 1st U.S. regulatory win with 510(k) clearance for the Sirius MRI marker.
C4 Imaging won clearance from the FDA for its 1st product, the Sirius Positive Signal MRI marker, designed for use following the treatment of prostate cancer with brachytherapy.
The MRI marker is designed to facilitate seed localization within the prostate, utilizing a single post-implant MRI procedure.
Brachytherapy involves implanting around 100 radioactive seeds into the prostate. It has risen in popularity because the treatment is considered more effective and convenient, according to the press release.
Healthcare regulators will take a closer look at missed efficacy endpoints and surgical risks associated with Boston Scientific's Watchman anti-stroke heart implant, which is slated this week to undergo FDA advisory panel review.
Boston Scientific (NYSE:BSX) may have to confront some tough questions when it faces a panel of FDA experts reviewing its Watchman stroke-preventing heart implant.
TYRX touts expanded 510(k) clearance for its AIGISRx N antibacterial envelope, now cleared for use with spinal cord neuromodulators.
TYRX won 510(k) clearance from the FDA to expand marketing indications for its AIGISRx N antibacterial envelope to include use with spinal cord neuromodulators.
The Monmouth Junction, N.J.-based company may now market the device as a tool to help reduce surgical site infections associated with implantable devices for both neurology and cardiology.
The FDA fines Ethicon's Advanced Sterilization Products business a total of $1.25 million over charges that the company shipped products with expiration dates that were not supported by data.
The U.S. Food & Drug Administration releases a list of pre-market approvals granted in August 2013.
Summary of PMA Originals & Supplements Approved
Summary of PMA Originals Under Review
Total Under Review: 55
Total Active: 21
Total On Hold: 34