|
Device | SynchroMed® Infusion System, 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 | S319 |
Date Received | 10/23/2018 |
Decision Date | 01/18/2019 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for labeling updates to the Model A820 myPTM app Patient User Guide used with the SynchroMed II Personal Therapy Manager (PTM). The labeling updates include the addition of pairing instructions for the patient to pair replacement parts of the PTM with the implanted pump and other minor clarifications |