PMA P860004S359

Device
SynchroMed Infusion System and Ascenda Intrathecal Catheters
Applicant
Medtronic, Inc.
PMA number
P860004
Supplement
S359
Product code
LKK
Decision date
2020-06-09
Generic name
Pump, infusion, implanted, programmable
Approval order statement
Modification of the final visual inspection procedure.

Current openFDA PMA Record#

Device
SynchroMed Infusion System and Ascenda Intrathecal Catheters
Applicant
Medtronic, Inc.
PMA number
P860004
Supplement
S359
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2020-06-09
Decision code
OK30
Date received
2020-05-11
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modification of the final visual inspection procedure.