|
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 | S278 |
Date Received | 05/01/2017 |
Decision Date | 05/31/2017 |
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 Changes made to the Gem 1000BK Ink Document M933254A to add a limitation for Use by Date (UBD) of 5 years from the date of manufacture, and add reference to ISO 10993-01:2009 standard for biocompatibility to align with current industry and Medtronic standards and practices. |