Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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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 | S026 |
Date Received | 01/09/2019 |
Decision Date | 02/04/2019 |
Withdrawal Date
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08/18/2021 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Changes to the Implantable System for Remodulin, including the implantable catheter, implantable catheter and revision kit, and the implantable infusion pump, which includes minor changes to the specification documentation, incoming inspection, manufacturing process and manufacturing validation. |
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