Recipient: Shelhigh Inc.
Product: Porcine Pulmonic Valve Conduits, Aortic Valve Conduits, Mitral Valve Conduits and other devices

Date:12/14/05

Failure to obtain premarket approval prior to offering products for sale; failure to follow written procedures for design control; failure to follow written procedures for design validation to include a risk analysis; failure to validate corrective and preventive actions; failure of Device History File to demonstrate that the design was developed following the approved design plan; failure to maintain complaint files; and other violations

FDA District: New Jersey District Office