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. |
|
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 | S334 |
Date Received | 07/12/2019 |
Decision Date | 03/23/2020 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for labeling changes for the Synchromed II and Isomed infusion systems including clarifications of the Ascenda catheter implant technique, the development of a standalone MRI guideline manual and updates to adverse event labeling/minor administrative changes. |
|
|