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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 NameMODEL 8810 SYNCHROMED PROGRAMMER
Classification Namepump, infusion, implanted, programmable
Generic Nameimplanted infusion pump
ApplicantMEDTRONIC VASCULAR
PMA NumberP860004
Supplement NumberS019
Date Received06/20/1991
Decision Date09/24/1991
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
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