2011-22107. Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Proposed rule; correction.

SUMMARY:

The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of August 8, 2011 (76 FR 48058). The document proposed to require the filing of a premarket approval application or a notice of completion of a product development protocol for the class III preamendments device: Cardiovascular permanent pacemaker electrode. The document was published with an incorrect Internet address for the first reference in the References section. This document corrects that error.

FOR FURTHER INFORMATION CONTACT:

Elias Mallis, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4622, Silver Spring, MD 20993-0002, 301-796-6216.

SUPPLEMENTARY INFORMATION:

In FR Doc. 2011-19959, appearing on page 48058, in the Federal Register of Monday, August 8, 2011, the following correction is made:

1. On page 48062, in the first column, under “XIII. References,” the first reference is corrected to read “1. Geiger, D.R., “FY 2003 and 2004 Unit Costs for the Process of Medical Device Review,” September 2005, http://www.fda.gov/​downloads/​MedicalDevices/​DeviceRegulationandGuidance/​Overview/​MedicalDeviceUserFeeandModernizationActMDUFMA/​ucm109216.”

Dated: August 24, 2011.

Nancy K. Stade,

Deputy Director for Policy, Center for Devices and Radiological Health.