PMA P140032S068
- Device
- Implantable System for Remodulin
- Applicant
- Medtronic, Inc.
- PMA number
- P140032
- Supplement
- S068
- Product code
- LKK
- Decision date
- 2021-04-01
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Implement ionic contamination monitoring to the SynchroMed II Infusion Pump.
Current openFDA PMA Record#
- Device
- Implantable System for Remodulin
- Applicant
- Medtronic, Inc.
- PMA number
- P140032
- Supplement
- S068
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2021-04-01
- Decision code
- OK30
- Date received
- 2021-03-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement ionic contamination monitoring to the SynchroMed II Infusion Pump.