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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 NameMEDTRONIC GEM DR MODEL 7271
Generic Namedual chamber implantable cardioverter defibrillator system
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS020
Date Received08/06/2001
Decision Date09/05/2001
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the alternate manufacturing and sterilization facility located at medtronic europe s. A. , tolochenaz, switzerland and an alternate packaging facility located at medtronic bv, kerkrade, the netherlands.
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