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 | SYNCHROMED & SYNCHROMED EL IMPLANTABLE PROGRAMMABLE INFUSION PUMPS |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S129 |
Date Received | 05/25/2010 |
Decision Date | 01/14/2011 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT BENCHMARK ELECTRONICS (THAILAND) PUBLIC COMPANY LIMITED IN AYUDHAYA, THAILAND FOR THE PURCHASING OF COMPONENTS, RECEIVING INSPECTION, PACKAGING, LABELING AND FINAL INSPECTION OF THE MODEL 8529 MAGNET AT THIS FACILITY. |
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