PMA P140032S065
- Device
- Implantable System for Remodulin
- Applicant
- Medtronic, Inc.
- PMA number
- P140032
- Supplement
- S065
- Product code
- LKK
- Decision date
- 2021-01-08
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Incorporate the Post Wafer Probe Check system to monitor the steps for all wafer lots that have completed wafer probe testing.
Current openFDA PMA Record#
- Device
- Implantable System for Remodulin
- Applicant
- Medtronic, Inc.
- PMA number
- P140032
- Supplement
- S065
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2021-01-08
- Decision code
- OK30
- Date received
- 2020-12-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Incorporate the Post Wafer Probe Check system to monitor the steps for all wafer lots that have completed wafer probe testing.