|
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 | S291 |
Date Received | 10/30/2017 |
Decision Date | 07/31/2018 |
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 for the Model A820 myPTM Application (myPTM App) and its labeling which is part of the new Model TH90 Personal Therapy Manager (PTM) system intended for use with the SynchroMed II infusion pump. |