SynchroMed Infusion System and Ascenda Intrathecal Catheters

FDA premarket approval P860004/S368 · decided 2021-08-30

Approval details

PMA number

P860004

Supplement

S368

Supplement type

135 Review Track For 30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

SynchroMed Infusion System and Ascenda Intrathecal Catheters

Generic name

Pump, infusion, implanted, programmable

Applicant

Medtronic, Inc.

Date received

2021-01-25

Decision date

2021-08-30

Days to decision

217 days

Decision code

APPR

Product code

LKK

Advisory committee

General Hospital

Expedited review

No

Location

Minneapolis, MN

Statement

Approval for a cleaning process change at DSM Biomedical in Berkeley California, a supplier to Medtronic Neuromodulation, that involves the addition of an option to replace solvent cleaning the equipment between material lots with a process that uses the next lot of material to purge the system (the first 30 seconds of material coming out of this portion of the manufacturing line is discarded). The change involves the continuous reactor system to be purged between production batches of same hard

510(k) clearances by this applicant