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 | S047 |
Date Received | 12/23/2019 |
Decision Date | 10/21/2020 |
Withdrawal Date
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08/18/2021 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for design and manufacturing changes for the remediated pump changes and labeling corrections for the Implantable System for Remodulin. |
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