|
Device | SynchroMed Infusion System and Ascenda Intrathecal Catheters |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S346 |
Date Received | 11/05/2019 |
Decision Date | 02/03/2020 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for update to the Model A810 SynchroMed II Clinician Programmer handling of the corrupted CRC calculation for certain memory locations and additional minor software changes to bring the device back into specifications for known anomalies. |