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PMA P860004S375

Device
SynchroMed Infusion System, Ascenda Intrathecal Catheters
Applicant
Medtronic, Inc.
PMA number
P860004
Supplement
S375
Product code
LKK
Decision date
2021-06-25
Generic name
Pump, infusion, implanted, programmable
Approval order statement
Newly defined and characterized solder paste inspection (SPI) process at Medtronic Tempe Campus (MTC), Medtronic’s internal supplier of hybrids used in the manufacturing of Medtronic Neuromodulation (Neuro) products.

Current openFDA PMA Record#

Device
SynchroMed Infusion System, Ascenda Intrathecal Catheters
Applicant
Medtronic, Inc.
PMA number
P860004
Supplement
S375
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2021-06-25
Decision code
OK30
Date received
2021-05-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Newly defined and characterized solder paste inspection (SPI) process at Medtronic Tempe Campus (MTC), Medtronic’s internal supplier of hybrids used in the manufacturing of Medtronic Neuromodulation (Neuro) products.