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 INFUSION SYSTEM |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S249 |
Date Received | 04/13/2016 |
Decision Date | 05/13/2016 |
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 tool change- Medtronic uses a third party vendor to manufacture sub-assembly components. The vendor would like to use a new arbor press which has press force monitoring capabilities, opposed to the current arbor press which does not have such capabilities. The force monitoring will be an internal process, and no device specifications are changed. |
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