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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+ PULSE GENERATORS
Classification Nameprogrammer, pacemaker
Generic Nameimplantable cardiac pacemaker pulse generator
Regulation Number870.3700
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP880006
Supplement NumberS034
Date Received09/28/2001
Decision Date10/25/2001
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Elimination of the in-process x-ray imaging of the microny and regency sc+ pulse generators.
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