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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 NameACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERS
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator
Regulation Number870.3610
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP880086
Date Received11/15/1988
Decision Date08/21/1989
Product Code
DXY[ Registered Establishments with DXY ]
Docket Number 89M-0363
Notice Date 09/13/1989
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
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