PMA P140032S047
- Device
- Implantable System for Remodulin
- Applicant
- Medtronic, Inc.
- Product code
- LKK
- Decision date
- 2020-10-21
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Approval for design and manufacturing changes for the remediated pump changes and labeling corrections for the Implantable System for Remodulin.
Current openFDA PMA Record#
- Device
- Implantable System for Remodulin
- Applicant
- Medtronic, Inc.
- PMA number
- P140032
- Supplement
- S047
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2020-10-21
- Decision code
- APPR
- Date received
- 2019-12-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for design and manufacturing changes for the remediated pump changes and labeling corrections for the Implantable System for Remodulin.