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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameREGENCY SC+, REGENCY SC, REGENCY SCX
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable cardiac pacemaker pulse generator
Regulation Number870.3610
ApplicantPACESETTER, INC.
PMA NumberP880006
Supplement NumberS029
Date Received07/22/1999
Decision Date01/28/2000
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
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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