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 | S387 |
Date Received | 02/08/2022 |
Decision Date | 09/02/2022 |
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 for a change in the formulation of the resin used in the plastic hub component (Styrene-Butadiene Copolymer), and replacement of the current Urethane Acrylate adhesive (Dymax 1136-M) with another Urethane Acrylate adhesive (Dymax 1405-M-UR-SC), which is used to attach the cannula to the hub. |
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