FDA.reportPublic FDA data

PMA P860004S352

Device
SynchroMed Infusion System
Applicant
Medtronic, Inc.
Product code
LKK
Decision date
2020-11-10
Generic name
Pump, infusion, implanted, programmable
Approval order statement
Approval for change of a new sterile packaging (sterile pack) sealing equipment. This change applies to the Refill Kits, Catheter Access Port (CAP) Kit and Catheter Patency Kit in use with the SynchroMed Infusion System Ascenda Intrathecal catheter and Implantable System for remodulin.

Current openFDA PMA Record#

Device
SynchroMed Infusion System
Applicant
Medtronic, Inc.
PMA number
P860004
Supplement
S352
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2020-11-10
Decision code
APPR
Date received
2020-01-17
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for change of a new sterile packaging (sterile pack) sealing equipment. This change applies to the Refill Kits, Catheter Access Port (CAP) Kit and Catheter Patency Kit in use with the SynchroMed Infusion System Ascenda Intrathecal catheter and Implantable System for remodulin.