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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 | S338 |
Date Received | 08/09/2019 |
Decision Date | 08/21/2020 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval to change the molding process for the SynchroMed Infusion System and Ascenda Intrathecal Catheters components(Fill Port Septum and the Catheter Access Port Septum). |