|
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 | S345 |
Date Received | 10/18/2019 |
Decision Date | 05/15/2020 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval to change to a PFOA-free manufacturing process on a component of the non-implanted Anchor Dispenser Tool using an existing approved sub-tier supplier. |