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Summary Information for: Access & #xae; Hybritech p2PSA on the Access Immunoassay Systems

June 20, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Access® Hybritech p2PSA on the Access Immunoassay Systems (P090026).

Consumer Information on: Access & #xae; Hybritech p2PSA on the Access Immunoassay Systems - P090026

June 20, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

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Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis

June 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This draft guidance document was developed as a special control guidance to support the reclassification of the Implanted Blood Access Devices for Hemodialysis into class II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..

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Consumer Information on: PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) - P110010/S001

June 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).

Add Cyber Security Evaluation to Device Design Process: Expert

June 15, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Medical devicemakers that don’t audit their products for computer security could be putting patients at risk, a cyber security expert says.

Grassley: FDA Unresponsive to Requests for & #8216;FDA Nine & #8217; Records

June 15, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

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.

PMA Final Decisions for April 2012

June 15, 2012 9:30 am | by U.S. Food & Drug Administration | News | Comments

These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for April 2012.

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Ethicon Asks FDA for 120 Days to Pull Vaginal Mesh From Market

June 8, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

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.

Device Tax Repeal Passes House, Industry Takes Battle to Senate

June 8, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

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 Salmonella

June 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.

Wrinkle Fillers Approved by the Center for Devices and Radiological Health

June 7, 2012 7:30 am | by U.S. Food & Drug Administration | News | Comments

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...

Introvale (levonorgestrel and ethinyl estradiol) Tablets: Recall - Packaging Flaw

June 6, 2012 1:30 pm | by U.S. Food & Drug Administration | News | Comments

Risk of an unintended pregnancy for a patient taking the wrong tablet over several days.

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Device Tax Repeal Measure Passes Committee, Sent To House Floor

June 1, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

The House Ways & Means Committee Thursday approved legislation, H.R. 436, to repeal the medical device excise tax — delighting industry.

House Overwhelmingly Passes MDUFA, Reconciliation With Senate Bill Is Next

June 1, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

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.

Reumofan Plus: Recall - Undeclared Drug Ingredient

June 1, 2012 10:30 am | by U.S. Food & Drug Administration | News | Comments

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 Fluid

June 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 Meeting

May 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

Teva’s Adderall 30 mg Tablets: Counterfeit Product - Contains Wrong Active Ingredients

May 30, 2012 4:30 am | by U.S. Food & Drug Administration | News | Comments

The counterfeit versions of Adderall should be considered as unsafe, ineffective and potentially harmful.

V Maxx RX: Recall - Undeclared Drug Ingredient

May 29, 2012 4:30 am | by U.S. Food & Drug Administration | News | Comments

Undeclared active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels.

UDI Rule Could See Light of Day Soon, OMB Sign-Off Expected, FDAer Says

May 25, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

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.

Final Senate MDUFA Package Omits Device Tax Repeal

May 25, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

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 Errors

May 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.

FDA Safety Communication: Dialysate Concentrates and Alkali Dosing Errors with Hemodialysis

May 25, 2012 6:31 am | by U.S. Food & Drug Administration | News | Comments

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...

Dialysate Concentrates Used in Hemodialysis: Safety Communication - Alkali Dosing Errors

May 25, 2012 6:30 am | by U.S. Food & Drug Administration | News | Comments

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.

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