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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameGEMINI(R) THETA MODEL 415A CARDIAC PACER
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namecardiac pacer
ApplicantTELECTRONICS PACING SYSTEMS, INC.
PMA NumberP830007
Date Received02/07/1983
Decision Date11/10/1983
Product Code
LWP[ Registered Establishments with LWP ]
Docket Number 83M-0389
Notice Date 12/07/1983
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S009 S010 
S012 S013 S014 S015 S016 S017 S018 S019 S020 
S021 S022 S023 S024 S025 S026 S027 S028 S029 
S030 S031 S032 
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