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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.
 
DeviceCORDIS SEQUICOR THETA MODELS 233D & 233E
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantTelectronics Pacing Systems, Inc.
7400 S. Tucson Way
Englewood, CO 80112
PMA NumberP820014
Supplement NumberS034
Date Received02/12/1988
Decision Date03/17/1988
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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