|
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 | S236 |
Date Received | 08/31/2015 |
Decision Date | 12/21/2015 |
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 CHANGES TO THE H2 CATHODE MIX PROCESS USED TO MANUFACTURE BATTERIES FOR IMPLANTABLE DEVICES. |