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 and Ascenda Intrathecal Catheters |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S347 |
Date Received | 11/15/2019 |
Decision Date | 12/11/2019 |
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 Update Medtronics manufacturing software, Manufacturing Execution System to Factory Works (Release 9.7), which is comprised of (1) FW Business Rule Client 9.7, (2) FW Configuration Client 9.2.2, and (3) Integrated Manufacturing Process Management (iMPM) Web Services (WS) 3.6. |
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