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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) MODELS 7219 B/D/E, 7202 B/D/E JEWEL PLUS 7220 B/D/E
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namepacing sys
ApplicantMEDTRONIC VASCULAR
PMA NumberP900061
Supplement NumberS013
Date Received06/26/1995
Decision Date04/15/1996
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for model 7219 b/d/e jewel(tm), model 7202 d/e/ jewel(tm), model 7220 b/d/e jewel plus device with endotak series leads.
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