PMA P140032S071
- Device
- Implantable System for Remodulin
- Applicant
- Medtronic, Inc.
- PMA number
- P140032
- Supplement
- S071
- Product code
- LKK
- Decision date
- 2021-06-02
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Implementation of new visual inspections and additional controls to the SynchroMed II pump head and pump tube assembly steps.
Current openFDA PMA Record#
- Device
- Implantable System for Remodulin
- Applicant
- Medtronic, Inc.
- PMA number
- P140032
- Supplement
- S071
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2021-06-02
- Decision code
- OK30
- Date received
- 2021-05-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of new visual inspections and additional controls to the SynchroMed II pump head and pump tube assembly steps.