Day

September 22, 2005
22
Sep

FDA Form 483 Guidant Corp.

September 22, 2005
Recipient: Guidant CorpProduct: Insignia Pacemaker Date: 9/22/05 There are no corrective and preventive actions to change design control procedures to identify or prevent memory overflow or similar software programming problems from recurring. Software used as part of production and the quality system has not been fully validated for its intended use according to an established...
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