|
Device | SynchroMed Infusion System, Ascenda Intratecal Catheters |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S330 |
Date Received | 04/22/2019 |
Decision Date | 10/16/2019 |
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 for the manufacturing change of the bi-wing anchor from transfer molding technology to liquid injection molding technology. |