|
Device | SynchroMed Intrathecal Catheters |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S363 |
Date Received | 08/26/2020 |
Decision Date | 11/18/2020 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for a minor design change to the Sutureless Catheter Seal Connector for catheter model number 8731SC and its revision kits model numbers 8578 and 8596SC for the SynchroMed Intrathecal Catheter; as well as the intravascular catheter model number 8201 for the Implantable System for Remodulin. |