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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 NameJEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namepacing sys
ApplicantMEDTRONIC VASCULAR
PMA NumberP900061
Supplement NumberS012
Date Received05/30/1995
Decision Date08/22/1995
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for medtronic, inc. , med-rel, road 909, km. 0. 4. , barrio mariana, humacao, puerto rico, to manufacture the model 7220 b/d/e jewel plus arrhythmia control system.
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