PMA P140032S006
- Device
- Implantable System for Remodulin
- Applicant
- Medtronic, Inc.
- PMA number
- P140032
- Supplement
- S006
- Product code
- LKK
- Decision date
- 2018-05-18
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Approval for changes to the Implantable System for Remodulin Technical Manual and Implantable System for Remodulin Patient Manual.
Current openFDA PMA Record#
- Device
- Implantable System for Remodulin
- Applicant
- Medtronic, Inc.
- PMA number
- P140032
- Supplement
- S006
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2018-05-18
- Decision code
- APPR
- Date received
- 2018-04-20
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the Implantable System for Remodulin Technical Manual and Implantable System for Remodulin Patient Manual.