Labeling, Approval Order, and Summary of Safety and Effectiveness for Access® Hybritech p2PSA on the Access Immunoassay Systems (P090026).
The Access® Hybritech p2PSA on the Access Immunoassay Systems is an automated laboratory test that measures how much [-2]proPSA a man has in his blood.
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Implanted Blood Access Devices for HemodialysisJune 20, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments
This draft guidance document was developed as a special control guidance to support the reclassification of the Implanted Blood Access Devices for Hemodialysis into class II (special controls). The device, as proposed, is intended to provide access to a..
Consumer Information on: PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) - P110010/S001June 18, 2012 10:30 am | by U.S. Food & Drug Administration | News | Comments
The PROMUS Element stent is a metal stent with the drug everolimus contained in a thin coating on the stent?s surface. The PROMUS Element stent is mounted on a folded balloon attached to a catheter delivery system for placement into a coronary artery...
Summary Information for: PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire)June 18, 2012 10:30 am | by U.S. Food & Drug Administration | News | Comments
Labeling, Approval Order, and Summary of Safety and Effectiveness for PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) (P110010S001).
Medical devicemakers that don’t audit their products for computer security could be putting patients at risk, a cyber security expert says.
Congressional lawmakers say the FDA is holding up their investigation into reports the agency monitored the personal emails of employees who voiced product safety concerns to Congress, noting that almost five months have gone by without an agency response to a request for key documents.
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for April 2012.
Johnson & Johnson’s (J&J) Ethicon unit will halt sales of some vaginal mesh products implicated in a class action lawsuit, but says it needs time to conduct the withdrawal properly.
Opponents of the medical device excise tax, mandated in the 2010 Affordable Care Act, are one step closer to repealing the contentious measure, after the House voted 270-146 to pass H.R. 436, the Protect Medical Innovation Act.
Digestive 3 in 1 Health Liquid Dietary Supplement: Recall - Potential for Contamination With SalmonellaJune 7, 2012 10:30 am | by U.S. Food & Drug Administration | News | Comments
Risk of serious and sometimes fatal infections, especially in young children, frail or elderly people, and others with weakened immune systems.
FDA approval is based on the review of data collected from controlled clinical studies that evaluated the safe and effective use of the wrinkle fillers when injected into specified areas of facial tissue. More information about the data FDA reviewed to...
Risk of an unintended pregnancy for a patient taking the wrong tablet over several days.
The House Ways & Means Committee Thursday approved legislation, H.R. 436, to repeal the medical device excise tax — delighting industry.
The House voted 387-5 Wednesday evening to pass an omnibus FDA user fee bill, giving lawmakers most of June to iron out differences between that measure and one the Senate passed May 24.
Product contains potentially harmful active pharmaceutical ingredients that may interact with other medications and result in serious adverse events.
MOOG Medical Devices Group, Curlin Infusion Administration Sets: Class I Recall - Potential for Reverse Flow of FluidJune 1, 2012 5:31 am | by U.S. Food & Drug Administration | News | Comments
Device malfunction may cause blood loss, an under-delivery of prescribed medicines or fluids, or a potential delay in therapy, leading to serious adverse health consequences, including death.
Amendment of Meeting Notice; June 27-28, 2012: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee MeetingMay 31, 2012 2:30 am | by U.S. Food & Drug Administration | News | Comments
Amendment of Meeting Notice; June 27-28, 2012: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting
The counterfeit versions of Adderall should be considered as unsafe, ineffective and potentially harmful.
Undeclared active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels.
The Office of Management and Budget (OMB) could release the FDA’s proposed rule on a unique device identification (UDI) system “any day now,” an agency official says, ending a nearly year-long delay in finalizing the much-anticipated safety mechanism.
The Senate voted 96-1 on Thursday to approve an omnibus FDA user fee bill, but earlier in the week rejected including an industry-backed amendment to repeal the upcoming medical device excise tax.
Baxa Corporation Abacus Total Parenteral Nutrition (TPN) Calculation Software: Class I Recall - Potential Dosing ErrorsMay 25, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments
Problems associated with mix-ups related to salt-based or ion-based ordering of electrolytes.
The FDA received a complaint describing alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate. When metabolized, these potential sources of alkali can contribute to elevated bicarbonate...
Risk of elevated bicarbonate levels in patients undergoing hemodialysis, which can contribute to metabolic alkalosis, a significant risk factor associated with cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia.