Document ID: FDA-2011-N-0505-0002
Agency: fda
Document Type: Proposed Rule
Title: Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode; Correction
Posted Date: 2011-08-30T04:00Z

[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Proposed Rules]
[Page 53851]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22107]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2011-N-0505]

Effective Date of Requirement for Premarket Approval for 
Cardiovascular Permanent Pacemaker Electrode; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; correction.

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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.
[FR Doc. 2011-22107 Filed 8-29-11; 8:45 am]
BILLING CODE 4160-01-P