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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.
 
DeviceGEMINI(R) THETA MODEL 415A CARDIAC PACER
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantTELECTRONICS PACING SYSTEMS, INC.
7400 SOUTH TUCSON WAY
ENGLEWOOD, CO 80112
PMA NumberP830007
Supplement NumberS005
Date Received01/08/1985
Decision Date04/09/1985
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
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