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 (ISR) |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Medtronic, Inc. 710 MEDTRONIC PARKWAY NE MINNEAPOLIS, MN 55432-5604 |
PMA Number | P140032 |
Supplement Number | S058 |
Date Received | 07/20/2020 |
Decision Date | 01/15/2021 |
Withdrawal Date
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08/18/2021 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval of a material change from polyvinyl chloride (PVC) to Methyl Methacrylate Acrylonitrile Butadiene Styrene (MABS) on the extension set component of the Model 201106 Refill Kit for the Implantable System for Remodulin (ISR). |
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