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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.
Classification Namesystem, esophageal pacing
Generic Nameexternal pulse generator
PMA NumberP840002
Date Received11/19/1984
Decision Date04/30/1986
Product Code
LPA[ Registered Establishments with LPA ]
Docket Number 86M-0237
Notice Date 07/01/1986
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S007 S008 S009 S010 S011 S012