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 | S054 |
Date Received | 04/16/2020 |
Decision Date | 05/14/2020 |
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 SynchroMed II Implantable Infusion Pump and Implantable System for Remodulin the creation of new supplier tooling, automation of an existing supplier test system, and modification of supporting component and device drawings for component assemblies. |
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