|
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 | S361 |
Date Received | 07/20/2020 |
Decision Date | 01/15/2021 |
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 of: a material change from polyvinyl chloride (PVC) to Methyl Methacrylate Acrylonitrile Butadiene Styrene (MABS) on the extension set component of the Model 8551 Refill Kit and Model 8540 CAP Kit for the SynchroMed Infusion System. |