|
Device | MEDTRONIC SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S264 |
Date Received | 11/21/2016 |
Decision Date | 12/20/2016 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for added in-process inspection and manufacturing note for a torque specification of a motor screw contained in the SynchroMed II (Model 8637) pump. |