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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 NameDEFENDER IV MODEL 612 DUAL-CHAMBER, RATE-RESPONSIVE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR, ELA MEDICAL PROMGRAMMER
Generic Nameimplantable cardioverter-defibrillator with active housing
ApplicantELA MEDICAL, INC.
PMA NumberP980049
Supplement NumberS001
Date Received10/15/1999
Decision Date05/18/2000
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for defender iv dr model 612.
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