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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 IMPLANTABLE INFUSION SYSTEM: PERCUTANEOUS INTRASPINAL CATHETER KIT
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pumps
ApplicantMEDTRONIC NEUROLOGICAL
PMA NumberP860004
Supplement NumberS078
Date Received11/28/2005
Decision Date03/10/2006
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for inclusion of the b. Braun medical perifix catheter connector in the model 8516 percutaneous intraspinal catheter kit.
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