Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | IMPLANTABLE SYNCHROMED II INFUSION PUMP |
Generic Name | pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 central avenue ne minneapolis, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S171 |
Date Received | 05/24/2012 |
Decision Date | 06/18/2012 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement MANUFACTURING CHANGE TO THE READING OF THE SERIAL NUMBER ON A COMPONENT FOR THE SYNCHROMED II IMPLANTABLE INFUSION PUMP, MODELS AND 8637-20 AND 8637-40. |
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