|
Device | Implantable System for Remodulin |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Medtronic, Inc. 710 MEDTRONIC PARKWAY NE MINNEAPOLIS, MN 55432-5604 |
PMA Number | P140032 |
Supplement Number | S006 |
Date Received | 04/20/2018 |
Decision Date | 05/18/2018 |
Withdrawal Date
|
08/18/2021 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for changes to the Implantable System for Remodulin Technical Manual and Implantable System for Remodulin Patient Manual. |