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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 NameCHORUS(R) MODEL 6001,3,33 DDD MODEL CPRI MODEL P2A
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pacemakers & programmer systems
ApplicantELA MEDICAL, INC.
PMA NumberP900022
Supplement NumberS003
Date Received11/07/1991
Decision Date03/13/1992
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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