PMA P860004S369
- Device
- Drug Delivery Infusion Pumps SynchroMed
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S369
- Product code
- LKK
- Decision date
- 2021-03-25
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- New supplier of the jewel bearing and plug stone subcomponents of the SynchroMed II motor subassembly.
Current openFDA PMA Record#
- Device
- Drug Delivery Infusion Pumps SynchroMed
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S369
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2021-03-25
- Decision code
- OK30
- Date received
- 2021-02-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New supplier of the jewel bearing and plug stone subcomponents of the SynchroMed II motor subassembly.