PMA P860004S387

Device: SynchroMed® Infusion System, Ascenda® Intrathecal Catheters
Applicant: Medtronic, Inc.
Product code: LKK
Decision date: 2022-09-02
Generic name: Pump, infusion, implanted, programmable
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.

Current openFDA PMA Record#

Device: SynchroMed® Infusion System, Ascenda® Intrathecal Catheters
Applicant: Medtronic, Inc.
PMA number: P860004
Supplement: S387
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2022-09-02
Decision code: APPR
Date received: 2022-02-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.