Medtronic, AtriCure and Cook to get panel review and PMA vote next month
The FDA’s circulatory system devices panel has Medtronic Inc. (NYSE:MDT), AtriCure Inc. (NSDQ:ATRC) and Cook Medical in its sights for panel review next month.
Medtronic and AtriCure are both hoping to get the panel’s nod for cardiac ablation devices, and Cook is working toward clearance for its drug-eluting stent.
Medtronic and Atricure prepare for FDA panel review in October
October 26-27, 2011: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
FDA to review Cook’s PMA for a drug-eluting stent on Oct. 13, 2011
October 13, 2011: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2011-N-0002]
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory Committee.
FDA releases August 2011 PMA approvals
The Food & Drug Administration released a list of pre-market approvals granted in August:
Mela Sciences surges on FDA nod
Shares of Mela Sciences (NSDQ:MELA) are on a tear today in pre-market trading on news that the FDA issued an “approvable letter” for its MelaFind skin cancer detection device.
Medtronic’s Ablation Frontiers device wins FDA panel date
Medtronic Inc. (NYSE:MDT) has a date with the FDA.
The Fridley, Minn.-based medical device maker is slated o go before the watchdog agency’s circulatory systems advisory panel Oct. 27 for a review of its pre-market approval application for the Ablation Frontiers cardiac ablation system.
The device, designed to treat atrial fibrillation, won a nod from Health Canada in August 2010, meaning it’s cleared for market north of the border.
FDA and AtriCure set a date for Synergy cardiac ablation device PMA panel review
AtriCure Inc.’s (NSDQ:ATRC) Synergy cardiac ablation system will undergo FDA panel review in late October as the watchdog agency considers the company’s premarket approval application.
Cardiac ablation uses either heat or cold to create precise scar tissue in the heart to correct arrhythmias, or heart rhythm problems.
FDA releases 180-day PMA memos
The FDA’s Center for Devices & Radiological Health released a selection of summary review memos detailing applications to make substantial changes to already-approved medical devices.
The federal watchdog agency’s med-tech oversight arm said it began releasing the documents as part of the CDRH’s transparency initiative. The 180-day supplements seek to make “a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report,” according to the agency.
FDA device reviewers get new training as Congressional Health panel targets med-tech
The FDA’s reviewer certification program will become an agency-wide requirement this month, aimed at shortening medical device review times through a more prepared staff.
The 18-month training program will apply to all new device reviewers from the Centers for Devices & Radiological Health’s anaesthesia, general hospital, infection control and dental devices divisions.
Former MDT CEO Hawkins in-depth, patent spats, hedge fund love, postmarket surveillance, FDA guidances, the CRM slump and Sen. Scott Brown at Covidien made headlines this week | MassDevice.com +7
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