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FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
Biotronik (BIOTRONIK SE & Co. KG; [1] [2] Biotronik Worldwide) is a limited partnership [1] multi-national cardiovascular biomedical research and technology company, headquartered in Berlin, Germany. The company offers equipment for diagnosis, treatment, and therapy support in the areas of cardiac rhythm management, electrophysiology , and ...
Floxuridine is a pyrimidine analog that acts as an inhibitor of the S-phase of cell division. This selectively kills rapidly dividing cells. Antimetabolites masquerade as pyrimidine-like molecules which prevents normal pyrimidines from being incorporated into DNA during the S phase of the cell cycle.
Myelosuppression, renal impairment, peripheral neuropathy, supraventricular tachycardia (uncommon), hepatitis (rare), colitis (rare), pneumonitis (rare), radiation recall (rare), Stevens–Johnson syndrome (rare) and toxic epidermal necrolysis (rare). Pralatrexate: IV
By early 1973, over 60 implanted Betacel-Biotronik pacemakers were being monitored as part of the clinical investigation. [ 3 ] [ 6 ] By mid-1974, the USAEC had authorized the licensing in the United States of a Clinical Investigation Program that allowed the implantation of 50 Betacel-Biotronik pacemakers per month in major clinics in the U.S ...
The FDA said the recall of the device BioZorb Marker, initiated by Hologic in March, was not a product removal, but a correction. The agency also urged patients to report any side effects they ...
Pacemaker syndrome is a condition that represents the clinical consequences of suboptimal atrioventricular (AV) synchrony or AV dyssynchrony, ...
Fluorouracil (5-FU, 5-fluorouracil), sold under the brand name Adrucil among others, is a cytotoxic chemotherapy medication used to treat cancer. [3] By intravenous injection it is used for treatment of colorectal cancer , oesophageal cancer , stomach cancer , pancreatic cancer , breast cancer , and cervical cancer . [ 3 ]