Consumer Information on: Prometra® Programmable Infusion Pump System

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: Prometra® Programmable Infusion Pump SystemPMA…

Norgestimate and Ethinyl Estradiol Tablets: Recall

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CDER World

Making the Work of CDER Transparent on the Web For many years, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) has reached out to its international regulatory colleagues. Since 2005, CDER has held the CDER Forum for International Drug Regulatory Authorities every spring and fall so international regulators can learn…

Class I Medical Device Recall: Nemschoff Chairs, Inc., Perinatal Pediatric Hospital Bed (Bassinet)

Recall Class: Class I Date Recall Initiated: October 14, 2011 Product: Perinatal Pediatric Hospital Bed (Bassinet) Model numbers: BSNT/01, BSNT/02, BSNT/03, BSNT/04 Manufacturing From: Models BSNT/01 and BSNT/02 were manufactured between 11/2003 and 02/2008. Models BSNT/03 and BSNT/04 were manufactured between 11/21/2003 to present. Use: The Nemschoff bassinet is intended for medical purposes for the…

CDRH Learn (New Courses Available

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