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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceREGENCY SC+, REGENCY SC, REGENCY SCX
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantSt. Jude Medical, Inc.
15900 VALLEY VIEW Court
SYLMAR, CA 91342
PMA NumberP880006
Supplement NumberS029
Date Received07/22/1999
Decision Date01/28/2000
Withdrawal Date 05/07/2018
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval is for the Model 3304 Programmer Software for use with the Model 3500 and Model 3510 Programmers. The device is indicated for the programming and interrogation of implanted St. Jude pacemakers.
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