|
Device | SynchroMed Infusion System |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S310 |
Date Received | 05/24/2018 |
Decision Date | 06/19/2018 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Reorganization of the resistance spot welding process (RSW) steps and a modification to the current RWS inspection process in the manufacturing line of the Synchromed II pump. |