|
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 | S253 |
Date Received | 06/09/2016 |
Decision Date | 07/07/2016 |
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 Addition of new peel test and pouch seal equipment used in the Pouch Sealing process and Blister Package and Pouch Peel Testing process and introduction of a new peel test operation procedure at the Medtronic Sullivan Lake facility. |