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 | SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S424 |
Date Received | 01/29/2024 |
Decision Date | 04/09/2024 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement approval for a minor design change to a Radio Frequency (RF) PIN Diode of the Telemetry-M (Tel-M) communication circuit and consequent minor change to the Printed Circuit Board (PCB) used on the Intellis 8880T2 (Clinician Telemetry Module, CTM2), 97745 / 97745FA (Programmer Patient Therapy Manager, PTM3), and 97745NT (Programmer Patient Therapy Manager, PTM3 No Bluetooth) |
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