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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 NameSYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pumps
ApplicantMEDTRONIC VASCULAR
PMA NumberP860004
Supplement NumberS056
Date Received04/07/2003
Decision Date09/12/2003
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the medtronic synchromed ii programmable drug infusion system which includes model 8637 synchromed ii programmable pump, synchromed ii application softwaare on the model 8870 application card, model 8551 refill kit, model 8540 catheter access port kit, and model 8590-1 pouch kit.
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