PMA P140032
- Device
- Implantable System for Remodulin
- Applicant
- Medtronic, Inc.
- PMA number
- P140032
- Supplement
- S074
- Product code
- LKK
- Decision date
- 2021-08-31
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Approval of Request for Post-Approval Study Termination.
Current openFDA PMA Record#
- Device
- Implantable System for Remodulin
- Applicant
- Medtronic, Inc.
- PMA number
- P140032
- Supplement
- S074
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2021-08-31
- Decision code
- APPR
- Date received
- 2021-08-04
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of Request for Post-Approval Study Termination.