FDA.reportPublic FDA data

PMA P860004S435

Device
Drug Delivery Infusion Pump/SynchroMed
Applicant
Medtronic, Inc.
PMA number
P860004
Supplement
S435
Product code
LKK
Decision date
2024-12-12
Classification
General Hospital
Generic name
Pump, infusion, implanted, programmable
Approval order statement
to allow supplier Mier Tool & Engineering Inc as an alternate supplier to provide the closing buttons for Medtronic Energy and Component Center (Located in Brooklyn Center, MN).

Current openFDA PMA Record#

Device
Drug Delivery Infusion Pump/SynchroMed
Applicant
Medtronic, Inc.
PMA number
P860004
Supplement
S435
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2024-12-12
Decision code
OK30
Date received
2024-11-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
to allow supplier Mier Tool & Engineering Inc as an alternate supplier to provide the closing buttons for Medtronic Energy and Component Center (Located in Brooklyn Center, MN).